- Acquired strategic assets from Phyxius
Pharma, including lead candidate levosimendan; named John Kelley as
CEO
- Activated sites for Phase 3 LEVO-CTS
trial for levosimendan in LCOS in the U.S., with data expected in
first calendar quarter of 2016
- Raised $55.0 million in net proceeds
through secondary offering in March 2014
- Conference call today at 8:30am ET
Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT) a specialty
pharmaceutical company focused on developing and commercializing a
portfolio of products for the critical care market, today announced
financial results for the fiscal year ended April 30, 2014, and
provided a corporate update.
“The last 9 months have truly been a transformative period for
the Company. Driven by the acquisition of our lead product
candidate, levosimendan, from Phyxius Pharma, we have quickly and
efficiently positioned Oxygen as a later-stage company with a
promising critical care portfolio and a well-funded clinical path
toward potential approval during the next several years,” said John
Kelley, Chief Executive Officer of Oxygen Biotherapeutics.
“That strategy is driven by our ongoing Phase 3 LEVO-CTS trial
for levosimendan in cardiac surgery patients at risk of developing
low cardiac output syndrome (LCOS). We have activated the first
sites for the Phase 3 trial and expect the first patient to be
enrolled soon. The U.S. Food and Drug Administration (FDA) has
already provided guidance that a single successful trial will be
sufficient to support approval, and we expect to report full
results from this study in the first calendar quarter of 2016,”
Kelley continued.
“Levosimendan provides us with a unique opportunity to test a
candidate that already has a significant clinical profile, with
data that suggests a potential benefit in not only LCOS, but also a
number of other critical care indications with high unmet needs.
With this clinical history to help guide our future development
plan in the U.S., we continue to push forward in LCOS while
simultaneously looking at other critical care indications where we
can drive additional value for both patients and our shareholders,”
Kelley concluded.
Recent Highlights
- In October 2013, Oxygen announced an
agreement to acquire certain assets of Phyxius Pharma, a
privately-held biopharmaceutical company, including the North
American rights to develop and commercialize levosimendan – a
calcium sensitizer developed for intravenous use that is being
prepared for a Phase 3 study to treat cardiac surgery patients at
risk for developing low cardiac output syndrome (LCOS). As part of
the agreement, the Company also announced the appointment of
Phyxius CEO John Kelley as the new CEO of Oxygen
Biotherapeutics.
- In January, Oxygen announced the
protocol for the Phase 3 LEVO-CTS trial for levosimendan, a
double-blind, randomized, placebo-controlled study that will
evaluate if levosimendan administered before and during cardiac
surgery can reduce the incidence of LCOS and associated morbidity
and mortality. Levosimendan has been granted Fast Track status, and
the FDA has also agreed to the protocol design under a Special
Protocol Assessment (SPA), and provided guidance that a single
successful trial will be sufficient to support approval of
levosimendan in this indication. The trial will be conducted by
Duke University’s Duke Clinical Research Institute (DCRI).
- In March, Oxygen announced it had
priced an underwritten public offering of 10,678,571 shares at a
public offering price of $5.60 per share, with net proceeds to the
company of approximately $55.0 million to help fund the Phase 3
LEVO-CTS trial.
- In March, Oxygen announced that the FDA
had lifted its clinical hold on the Company’s Oxycyte development
program, which is in Phase 2 studies for traumatic brain injury
(TBI).
- In April, Oxygen announced the
appointment of industry veteran Gerald Proehl, the former President
and CEO of Santarus, Inc., to the company’s Board of
Directors.
- In June, the Company announced the
formation of a steering committee for its Phase 3 LEVO-CTS trial,
including experts in the fields of cardiology, cardiac surgery,
cardiac anesthesia and clinical trials. John H. Alexander, M.D.,
M.H.S, Director of Cardiovascular Research, DCRI, will serve as the
Committee Chair.
- In February and June, Oxygen
highlighted multiple studies and academic review articles
concerning the current clinical profile and use of levosimendan,
and its potential benefits in a broad range of critical care
indications including cardiac surgery, cardiogenic shock, high-risk
non-cardiac surgery, septic shock, and acute kidney injury.
- In July, activated first sites for
Phase 3 trial LEVO-CTS trial for levosimendan, with first patient
enrolled expected soon.
Upcoming Expected Milestones
- Initiation of Phase 3 LEVO-CTS trial
for levosimendan in the third calendar quarter of 2014, with a goal
of enrolling 760 patients undergoing coronary artery bypass grafts
(CABG) and/or mitral valve surgery that are at risk for developing
LCOS
- Expected event rate interim analysis
following enrollment of 200 patients in LEVO-CTS trial, by the
first calendar quarter of 2015
- Two interim analyses during LEVO-CTS
trial testing for efficacy or futility after 50% and 70% of the
planned primary endpoint events have been recorded, in the second
half of 2015
- Last patient of LEVO-CTS trial in the
fourth calendar quarter of 2015
- Full data from Phase 3 LEVO-CTS trial
in first calendar quarter of 2016
Fiscal Year 2014 Financial Results
In its fiscal year ended April 30, 2014, the Company recognized
$263,000 in grant revenue, compared to $1.1 million in the prior
year as the Company closed out the majority of its preclinical
safety studies for Oxycyte under a U.S. Army sponsored
cost-reimbursement grant awarded in fiscal year 2012.
The Company reported a net loss of $19.5 million or $2.71 per
share for the fiscal year 2014, compared to a net loss of $9.4
million, or $6.29 per share in the prior year, reflecting increases
in compensation costs, legal and professional fees and research and
development expenses. In addition, 2014 net loss included $7.9
million in non-cash compensation expenses recognized from vesting
of performance-based stock options and restricted stock grants
attributable to the acquisition of the license rights to develop
levosimendan from Phyxius Pharma.
The Company reported research and development expenses of $3.0
million in fiscal year 2014 compared to $2.5 million in the prior
year. The increase in research and development expenses reflect the
Company's investment in its late-stage clinical programs during
2014, including the concurrent initiation of the Phase 3 study for
levosimendan and continuation of the Phase 2 study for Oxycyte.
At the end of fiscal year 2014, the Company had $58.3 million in
cash compared to $0.8 million at the end of the prior year,
reflecting several transactions in the fiscal year, including
proceeds from the March 2014 $59.8 million public offering of
Common Stock; proceeds from the July 2013 $5.4 million public
offering of Series C Preferred Stock and Warrants, and the exercise
of certain outstanding warrants of $7.0 million.
Financial Guidance
The Company expects its April 30, 2014 cash balance to be
sufficient for it to execute its corporate goals through fiscal
year 2017.
Michael Jebsen, Chief Financial Officer, said "In 2014, we
significantly expanded our product portfolio with the licensing of
levosimendan. We also strengthened our management team with
the addition of John Kelley as our CEO and two other key
appointments in research and development and commercial
organization. With the completion of our $59.6 million
offering in March, we solidified our balance sheet and are now
well-positioned with sufficient funds to complete our Phase 3
LEVO-CTS trial and carry the program through potential approval.
Our clinical execution and efficient use of capital also gives us
the flexibility to evaluate strategic opportunities for growth,
including potential additional indications for levosimendan.”
Conference Call
The Oxygen management team will host a call today at 8:30am ET
to discuss financial results for the fiscal year.
To participate in the call, please dial 877‐407‐8029 (domestic)
or 201‐689‐8029 (international) and refer to conference ID
13585285. A live webcast of the call can be accessed under “Events
and Presentations” in the Investors section of the Company’s
website at www.oxybiomed.com.
An archived webcast recording will be available on the Oxygen
Biotherapeutics website beginning approximately two hours after the
call.
About Levosimendan
Levosimendan is a calcium sensitizer developed for intravenous
use in hospitalized patients with acutely decompensated heart
failure. It was discovered and developed by Orion Pharma, Orion
Corporation of Espoo Finland, and is currently approved in over 50
countries for this indication and not available in the United
States. Oxygen Biotherapeutics recently acquired the North American
rights to develop and commercialize levosimendan from Phyxius
Pharma. The United States Food and Drug Administration (FDA) has
granted Fast Track status for levosimendan for the reduction of
morbidity and mortality in cardiac surgery patients at risk for
developing Low Cardiac Output Syndrome (LCOS). In addition, the FDA
has agreed to the Phase 3 protocol design under Special Protocol
Assessment (SPA), and provided guidance that a single successful
trial will be sufficient to support approval of levosimendan in
this indication.
About Oxygen Biotherapeutics
Oxygen Biotherapeutics, Inc. is a specialty pharmaceutical
company focused on developing and commercializing a portfolio of
products for the critical care market. The company recently
acquired the North American rights to develop and commercialize
levosimendan, and the United States Food and Drug Administration
(FDA) has granted Fast Track status for levosimendan for the
reduction of morbidity and mortality in cardiac surgery patients at
risk for developing Low Cardiac Output Syndrome (LCOS). The company
plans to start a Phase 3 trial with levosimendan in that indication
during the third calendar quarter of 2014, and has also developed a
proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called
Oxycyte® that is currently in clinical and preclinical studies for
intravenous delivery for indications such as traumatic brain
injury, decompression sickness and stroke.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by
the company that involve risks and uncertainties and reflect the
company’s judgment as of the date of this release. The
forward-looking statements are subject to a number of risks and
uncertainties, including, matters beyond the company's control that
could lead to delays in the clinical study, delays in new product
introductions and customer acceptance of these new products, and
other risks and uncertainties as described in the company’s filings
with the Securities and Exchange Commission, including in its
quarterly report on Form 10-Q filed on March 17, 2014, and annual
report on Form 10-K filed on June 26, 2013, as well as its other
filings with the SEC. The company disclaims any intent or
obligation to update these forward-looking statements beyond the
date of this release. Statements in this press release regarding
management’s future expectations, beliefs, goals, plans or
prospects constitute forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995.
Stern Investor RelationsJesse Baumgartner,
212-362-1200jesse@sternir.com
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