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deciding to invest in shares of our common stock.
ImaRx
Therapeutics, Inc.
Overview
We are a biopharmaceutical company developing and
commercializing therapies for vascular disorders. Our research
and development efforts are focused on therapies for stroke and
other vascular disorders, using our proprietary microbubble
technology to treat vascular occlusions, or blood vessel
blockages, as well as the resulting ischemia, which is tissue
damage caused by a reduced supply of oxygen. Our
commercialization efforts are currently focused on our product
approved by the U.S. Food and Drug Administration, or FDA,
for the treatment of acute massive pulmonary embolism, or blood
clots in the lungs.
According to the American Heart Association, approximately
one-third of adults in the United States have some form of
cardiovascular disease. Over eight million people in the
U.S. are afflicted each year with complications related to
blood clots. Approximately 700,000 adults in the U.S., or one
every 45 seconds, are afflicted with, and 150,000 die as a
result of, some form of stroke each year. Stroke is currently
the third leading cause of death, and the leading cause of
disability, in the United States. Approximately three million
Americans are currently disabled from stroke. The American
Stroke Association estimates that approximately
$62.7 billion will be spent in the U.S. in 2007 for
stroke-related medical costs and disability.
The vast majority of strokes, approximately 87% according to the
American Stroke Association, are ischemic strokes, meaning that
they are caused by blood clots, while the remainder are the more
deadly hemorrhagic strokes caused by bleeding in the brain.
Currently available treatment options for ischemic stroke are
subject to significant therapeutic limitations. For example, the
most widely used treatment for ischemic stroke is a
clot-dissolving, or thrombolytic, drug that can be administered
only during a narrow time window and poses a risk of bleeding,
resulting in 6% or less of ischemic stroke patients receiving
such treatment. To facilitate increased administration of stroke
therapies, in 2005 the Centers for Medicare and Medicaid
Services, or CMS, responded to requests by the American Stroke
Association and related groups for higher reimbursement amounts
for ischemic stroke patients treated with a thrombolytic drug by
approximately doubling the amount of reimbursement provided for
such treatment to $11,578 per patient.
In addition to the brain and the lungs, blood clots can block
blood flow and cause damage to other tissues in the body such as
the heart, in the case of coronary arterial disease, and the
legs and other extremities, in the case of peripheral vascular
disease. We believe our development and research stage products
may address significant unmet medical needs not only for stroke
but also for clot-induced damage in tissues other than the brain.
Our
Commercial and Development Stage Products
The following table summarizes the status of our commercial
product and development stage product candidates:
SonoLysis Program.
Our SonoLysis program is
focused on the development of two product candidates that
involve the administration of our proprietary MRX-801
microbubbles and ultrasound, with or without a thrombolytic
drug, to break up blood clots and restore blood flow to oxygen
deprived tissues. SonoLysis
+tPA
therapy involves the
administration of MRX-801 microbubbles, ultrasound and the
thrombolytic drug alteplase, or tPA. SonoLysis therapy comprises
the administration of MRX-801 microbubbles and ultrasound
without a thrombolytic drug. Our MRX-801 microbubbles are a
proprietary formulation of a lipid shell encapsulating an inert
biocompatible gas. We believe the
sub-micron
size of our MRX-801 microbubbles allows them to penetrate a
blood clot, so that when ultrasound is applied their expansion
and contraction, or cavitation, can break the clot into very
small particles. We believe that these product candidates have
the potential to treat a broad variety of vascular disorders
associated with blood clots.
Our initial therapeutic focus for our SonoLysis program is
ischemic stroke. The only FDA approved drug for the treatment of
ischemic stroke is tPA. The FDA has restricted tPA’s use to
patients who are able to begin treatment within three hours of
onset of ischemic stroke symptoms and who do not have certain
risk factors for bleeding, such as recent surgery or taking
medications that prevent clotting. According to Datamonitor,
approximately 23% of ischemic stroke patients arrive at a
hospital within three hours of onset of symptoms. However, due
to the three-hour window for treatment and other limitations,
only 1.6% to 2.7% of patients with ischemic stroke in community
hospitals, and only 4.1% to 6.3% in academic hospitals or
specialized stroke centers are treated with a thrombolytic
therapy. For these patients who are eligible for treatment with
tPA, we believe SonoLysis
+tPA
therapy may have advantages
over tPA alone, including more rapid and complete restoration of
blood flow. In addition, we believe our SonoLysis therapy may
have an improved bleeding and safety profile over tPA and
therefore may represent a new treatment option for ischemic
stroke patients ineligible for treatment with tPA by extending
the treatment window beyond three hours from onset of symptoms,
as well as broadening treatment availability to patients for
whom tPA is contraindicated due to risk of bleeding. Our two
SonoLysis product candidates being developed as potential
treatments for ischemic stroke are further described below:
•
SonoLysis+tPA therapy
involves the administration of our
proprietary MRX-801 microbubbles and ultrasound in conjunction
with tPA. To administer our SonoLysis
+tPA
therapy,
MRX-801 microbubbles and tPA are injected intravenously into the
bloodstream. The MRX-801 microbubbles are distributed naturally
throughout the body including to the site of the blood clot.
Ultrasound is then administered to the site of the blood clot,
and the energy from the ultrasound causes the MRX-801 to expand
and contract vigorously, or cavitate. We believe this cavitation
both mechanically breaks up the blood clot and helps the
administered tPA permeate the clot to facilitate clot dissolving
activity. The gas released by the MRX-801 microbubbles is then
cleared from the body simply by exhaling, and the lipid shell is
metabolized like other fats in the body. We believe that this
therapeutic approach incorporates two complementary mechanisms
of action, mechanical and enzymatic, that together can reduce
the time required to dissolve a blood clot and help ensure more
rapid and complete restoration of blood flow to at risk brain
tissues in patients with ischemic stroke. We are conducting a
Phase I/II dose-escalation clinical trial evaluating
SonoLysis
+tPA
therapy in patients with ischemic stroke.
We initiated this trial in January 2007, and intend to enroll a
total of 72 patients in various medical centers in the
United States and Europe. Patients will be enrolled into one of
four successive cohorts, or groups, that will receive escalating
doses of our MRX-801 microbubbles and the standard dose of tPA.
A Data and Safety Monitoring Board will review the data from
each cohort before granting approval to enroll patients in the
succeeding cohort utilizing the next higher dose of MRX-801
microbubbles. We anticipate enrollment for this trial will be
completed in the first half of 2008 and intend to initiate a
Phase II study following completion of the ongoing
Phase I/II study. We estimate that if approved by the FDA,
over 90,000 ischemic stroke patients in the U.S. could be
eligible for SonoLysis
+tPA
therapy annually.
•
SonoLysis therapy
involves administration of our MRX-801
microbubbles with ultrasound, but without the administration of
a thrombolytic drug. To administer our SonoLysis therapy,
MRX-801 microbubbles are injected intravenously into the
bloodstream and disperse naturally throughout the body including
to the site of the blood clot. Ultrasound is then administered
to the site of the blood clot, and
the energy from the ultrasound causes the MRX-801 microbubbles
to cavitate. We believe this cavitation mechanically breaks up
the blood clot and also helps to enhance the body’s natural
clot dissolving processes. The gas released by the MRX-801
microbubbles is then cleared from the body simply by exhaling,
and the lipid shell is processed like other fats in the body.
Because SonoLysis therapy does not involve use of a thrombolytic
drug and its associated risk of bleeding, we believe SonoLysis
therapy may offer advantages over existing treatments for
ischemic stroke, including extending the treatment window beyond
three hours from onset of symptoms and broadening treatment
availability to patients for whom thrombolytic drugs are
contraindicated due to risk of bleeding. We have not yet
conducted any clinical trials using our proprietary MRX-801
microbubbles with ultrasound to treat blood clot indications
without a thrombolytic drug. We are conducting and intend to
conduct additional preclinical studies of SonoLysis therapy
through the first half of 2008. We expect to initiate a
Phase II study to treat patients with ischemic stroke
following completion of our SonoLysis
+tPA
therapy
Phase I/II
clinical trial. Because of the preclinical data package as well
as our ongoing
Phase I/II
clinical trial evaluating SonoLysis
+tPA
therapy in
patients with ischemic stroke, we believe no Phase I study
will be required prior to initiating the Phase II study for
SonoLysis therapy. We estimate that if approved by the FDA, over
200,000 ischemic stroke patients in the U.S. could be
eligible for SonoLysis therapy annually.
Abbokinase.
Our commercially available
urokinase product, which we market as Abbokinase, is a
thrombolytic drug. Urokinase is a natural human protein
primarily produced in the kidneys that stimulates the
body’s natural clot-dissolving processes. Abbokinase is FDA
approved and marketed for the treatment of acute massive
pulmonary embolism. Abbokinase has been administered to over
four million patients, and we estimate that approximately 400
acute care hospitals in the U.S. include Abbokinase on
their pharmacy formulary today. We acquired Abbokinase,
including approximately a four-year supply of inventory, from
Abbott Laboratories in April 2006, and began selling Abbokinase
in October 2006. We believe Abbokinase sales will provide us
with near-term revenue and an opportunity to form relationships
with vascular physicians and acute care institutions that
regularly administer blood clot therapies. Approximately 74% of
our Abbokinase inventory as of March 31, 2007, will no
longer be saleable after October 2007 based on current
expiration labeling. In order to facilitate obtaining an
extension of current expiration dates, we intend to continue the
stability testing program started by Abbott Laboratories, which
has been ongoing for over four years. Based on the testing to
date, which has shown that the product changes very little from
year to year, we believe it is probable that the stability data
will support extension of the inventory expiration dates. In
connection with our Abbokinase acquisition, we issued a
$15.0 million non-recourse promissory note that matures in
December 2007. If we are unable to satisfy this debt obligation
when due, Abbott Laboratories will have the right to reclaim our
remaining inventory of Abbokinase, along with a portion of the
cash we have received from our sales of Abbokinase. In April
2007 we shipped approximately $9.0 million of Abbokinase,
net of discounts and fees, to two of our primary wholesalers, of
which, upon receipt of collections on the related accounts
receivable, approximately $4.0 million will be placed into
an escrow account as security for repayment of our
$15.0 million non-recourse promissory note due in December
2007. If the escrowed amount were to be applied to the
outstanding balance of principal and accrued interest on that
note, the remaining balance due under the note would be
approximately $11.9 million as of May 31, 2007.
The following table summarizes the status of our research stage
product candidates:
Research
Product Candidate
Product Elements
Indication(s)
Status
SonoLysis therapy
• MRX-801 microbubbles
Ischemic stroke in pre-hospital
setting
Preclinical
• Ultrasound
SonoLysis
+tPA
therapy
• MRX-801 microbubbles
Myocardial infarction
Preclinical
• Ultrasound
• tPA
Peripheral arterial occlusive
disease
Preclinical
Deep vein thrombosis
Preclinical
NanO
2
tm
• MRX-804
emulsion/microbubbles
Hemorrhagic shock
Preclinical
Neuroprotection for ischemic stroke
Research
Targeted SonoLysis therapy
• MRX-802 targeted
microbubbles
Myocardial infarction and other
vascular clots
Research
Targeted drug delivery
• MRX-803 targeted drug
delivery microbubbles
Angiogenic tumors
Research
Additional SonoLysis Opportunities.
We believe
SonoLysis therapy may be suitable for administration for
ischemic stroke in an ambulance before arriving at a hospital
because it does not involve use of a thrombolytic drug and its
associated risk of bleeding. To pursue an ambulance-based
ischemic stroke treatment, we would be required to show either
that hemorrhage can be ruled out in an ambulance setting, or
that SonoLysis therapy has no detrimental effect on a
hemorrhagic stroke. Additionally, we believe that the ability of
our SonoLysis
+tPA
therapy to reduce the time required to
dissolve a blood clot could make this therapy suitable for use
in treating a broad variety of vascular disorders beyond
ischemic stroke. For example, we believe SonoLysis
+tPA
therapy could potentially enable more rapid treatment of
recently formed acute clots, such as those that cause myocardial
infarction, or heart attack. We also believe SonoLysis
+tPA
therapy has the potential to treat more established
sub-acute
and chronic clots, such as those in peripheral vascular
indications that cannot be effectively treated with thrombolytic
therapy alone. We have used microbubbles and ultrasound with a
thrombolytic drug both to conduct preclinical animal studies
with academic collaborators to treat myocardial infarction, as
well as to conduct clinical proof of concept trials to treat
patients with occluded dialysis grafts, peripheral artery
occlusive disease and deep vein thrombosis. In many countries,
we believe that various risk factors for formation of blood
clots, such as high blood pressure, obesity, diabetes, aging
population, and limited mobility caused by injury, illness or
simply long distance air travel, are increasing, resulting in a
growing unmet medical need that we believe our SonoLysis product
candidates could address, potentially reducing the need for
angioplasty, stents and vascular surgery.
Other Research Stage Opportunities.
We are
exploring a number of potential future product development
opportunities based on our microbubble technology, including:
•
Oxygen Delivery.
We are investigating the
potential use of our proprietary MRX-804 emulsion/microbubbles,
which we call
NanO
2
,
to carry oxygen to parts of the body as a potential treatment
for a broad variety of disorders in which reduced blood flow
results in oxygen-deprived tissues, such as ischemic stroke,
heart attack, and injuries that involve significant blood loss,
or hemorrhagic shock.
NanO
2
is administered intravenously as an emulsion. We believe upon
entering the bloodstream it converts from a liquid to a gas,
forming microbubbles with a high oxygen carrying capacity. We
are working with an academic collaborator who has recently
received an approximately $700,000 grant from the
U.S. Department of Defense to conduct preclinical animal
studies of MRX-804 microbubbles to treat hemorrhagic shock. We
believe our
NanO
2
product candidate may have the ability to be stored
at room temperature, which could make it suitable for emergency
battlefield or ambulance-based treatments.
•
Targeted SonoLysis Therapy.
Our research team
has developed MRX-802, our next generation SonoLysis
microbubbles with targeting technology that causes the
microbubbles to bind to blood clots. We have demonstrated in
laboratory experiments that our MRX-802 targeted microbubbles
improve binding to blood clots. We believe that our MRX-802
targeted microbubbles will have a greater ability to
break-up
blood clots than non-targeted microbubbles when combined with
ultrasound. We have conducted preclinical animal studies with
academic collaborators evaluating MRX-802 targeted microbubbles
and ultrasound to treat various clot disorders, including
myocardial infarction. To further the research on our next
generation SonoLysis technology, we have received and are near
the mid-point of our work on an approximately $1.2 million
grant from the National Institutes of Health, or NIH, to study
MRX-802 targeted microbubbles to treat vascular clots.
•
Targeted Drug Delivery.
We have also developed
targeted drug delivery microbubbles, known as MRX-803, which
have the potential for selective drug delivery when used in
conjunction with ultrasound. MRX-803 is comprised of a gas core,
an oil containing a drug payload and a lipid shell. We have
received an approximately $1.0 million subcontract and have
reached the mid-point of our research on an NIH grant to study
the use of our proprietary MRX-803 targeted drug delivery
microbubbles to treat a variety of tumors. We believe this
technology has the potential for broad applications, including
delivering drugs to dissolve blood clots or arterial plaque as
well as to treat a variety of types of cancer.
Our
Business Strategy
Our goal is to become the leading provider of therapies for
stroke and other vascular disorders by developing and marketing
products to treat occlusions as well as the resulting ischemia.
The key elements of our business strategy are to:
•
develop and commercialize our SonoLysis product candidates to
expand the number of ischemic stroke patients who are eligible
for treatment;
•
sell our Abbokinase inventory and benefit from our commercial
relationships;
•
leverage our SonoLysis product candidates to accelerate
initiation of treatment for ischemic stroke in an ambulance
setting and address additional clot disorders in cardiology and
peripheral vascular disease; and
•
create a deep pipeline of products based on our microbubble
technologies to address additional indications.
Risks
Related to Our Business and Business Strategy
Our business is subject to numerous risks that could prevent us
from successfully implementing our business strategy. These
risks are highlighted in the section entitled “Risk
Factors” immediately following this prospectus summary, and
include the following:
•
we have a history of operating losses, including an accumulated
deficit of approximately $65.5 million and an overall
stockholders’ deficit of approximately $32.7 million
at March 31, 2007, and expect to continue to incur
substantial losses for the foreseeable future;
•
we will need substantial additional capital to fund our
operations;
•
we may never complete clinical development of our product
candidates or have more than one product approved for marketing,
and even if approved, our product candidates may never achieve
market acceptance;
•
failure to comply with various government regulations in
connection with the development, manufacture and
commercialization of our product candidates, and post-approval
manufacturing and marketing of
our products, could result in significant interruptions or
delays in our development and commercialization activities;
•
we may not be able to sell our inventory of Abbokinase at such
times, in such quantities, and at such prices as we anticipate,
or at all;
•
if we are unable to meet testing specifications for extension of
the label expiration dates currently applicable to about 74% of
our Abbokinase inventory, we will not be allowed to continue
selling it after October 2007;
•
if we fail to satisfy our December 2007 debt obligation to
Abbott Laboratories, Abbott Laboratories could reclaim our
remaining inventory of Abbokinase, along with the portion of the
cash we have received from our sales of Abbokinase that is in an
escrow account; and
•
we compete against companies that have longer operating
histories, more established products and greater resources than
we do.
In addition, our independent registered public accounting firm
has expressed doubt as of May 4, 2007 about our ability to
continue as a going concern.
Our
Corporate Information
We were organized as an Arizona limited liability company on
October 7, 1999, which was our date of inception for
accounting purposes. We were subsequently converted to an
Arizona corporation on January 12, 2000, and then
reincorporated as a Delaware corporation on June 23, 2000.
Our principal executive offices are located at
1635 E. 18th St., Tucson, Arizona 85719, and our
telephone number at that location is
(520) 770-1259.
Our corporate website address is www.imarx.com. The information
contained in or that can be accessed through our corporate
website is not part of this prospectus. Unless the context
indicates otherwise, as used in this prospectus, the terms
“ImaRx,” “we,” “us” and
“our” refer to ImaRx Therapeutics, Inc., a Delaware
corporation.
We have rights to use
Abbokinase
®
,
which is a U.S. registered trademark owned by Abbott
Laboratories. We use
SonoLysis
tm
,
NanO
2
tm
and the ImaRx Therapeutics logo as trademarks in the U.S. and
other countries. All other trademarks and trade names mentioned
in this prospectus are the property of their respective owners.
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