Miravant Medical Technol... (CE) (USOTC:MRVT)
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Miravant Medical Technologies (OTCBB:MRVT), a
pharmaceutical development company specializing in PhotoPoint(R)
photodynamic therapy (PDT), announced consolidated financial results
for the third quarter ended September 30, 2005. The net loss for the
quarter was $3.5 million or ($0.09) per share, compared to a net loss
of $3.4 million, or ($0.10) per share, for the same period in 2004.
The net loss for the nine months ended September 30, 2005, was $12.1
million or ($0.32) per share, compared to a net loss of $12.6 million
or ($0.40) per share for the same period in 2004.
The Company had cash and cash equivalents of $3.9 million at
September 30, 2005. The Company may also have the ability to borrow
under its March 2005 $15.0 million convertible line of credit, subject
to certain conditions and restrictions, including the discretionary
approval of the lender which may limit our borrowing availability
especially given the current financial condition and current stock
price of the Company.
"After many months of preparation, we are excited to have
commenced our Phase III confirmatory clinical trial for PHOTREX(TM)
for the treatment of wet age-related macular degeneration (AMD). This
is a major accomplishment for any company and we thank all those that
have worked so tirelessly to move this program forward to what we hope
will be its final stage," stated Robert J. Sutcliffe, Miravant's
chairman. "We hope to have full enrollment in this trial by mid-year
2006 with a primary efficacy analysis at 12 months (one year after
initial treatment), at which time the Company expects to amend its
previously filed New Drug Application (NDA) to seek marketing
approval."
On July 8, 2005, the Company announced that its board of directors
had accepted the resignation of Gary S. Kledzik, Ph.D., as chief
executive officer (CEO), chairman and director. The Company's board of
directors named director Robert J. Sutcliffe as Miravant's new,
non-executive chairman, and announced the appointment of an interim
executive committee consisting of Robert J. Sutcliffe and director
Rani Aliahmad to coordinate management functions, identify CEO
candidates and recommend initiatives to increase productivity and
leverage Miravant's development programs.
The Company confirmed that patient enrollment in the confirmatory
Phase III clinical trial of PHOTEX(TM) for treating wet AMD is
underway. This multi-center, placebo controlled study is a
confirmatory trial designed to fulfill the requirements for additional
clinical data as outlined in an "approvable" letter received from the
FDA following its review of the Company's NDA submission.
Miravant has contracted with Kendle (Nasdaq:KNDL), a leading
global full-service clinical research organization, to provide
clinical development and trial management services for this trial,
which is being conducted at approximately 50 investigational sites in
the United Kingdom, Central and Eastern Europe. This randomized,
placebo-controlled trial, reviewed by the U.S. Food and Drug
Administration under a Special Protocol Assessment (SPA), includes a
range of patients with both the classic and occult forms of wet AMD.
About Miravant
Miravant Medical Technologies (www.miravant.com) specializes in
PhotoPoint(R) photodynamic therapy (PDT), developing light-activated
drugs to selectively target diseased cells and blood vessels.
Miravant's primary areas of focus are ophthalmology and cardiovascular
disease with new drugs in clinical and preclinical development.
PHOTREX(TM) (rostaporfin), the Company's most advanced drug, has
received an FDA Approvable Letter as a treatment for wet age-related
macular degeneration and a SPA for this Phase III confirmatory
clinical trial. Miravant's cardiovascular development program,
supported in part by an investment from Guidant Corporation, focuses
on life-threatening coronary artery diseases, with PhotoPoint MV0633
in advanced preclinical testing for atherosclerosis, vulnerable plaque
and restenosis.
Safe Harbor Statement under the Private Securities Litigation
Reform Act of 1995
The statements contained in this press release that are not purely
historical are forward-looking statements within the meaning of
Section 21E of the Securities and Exchange Act of 1934, as amended.
Such forward-looking statements included in this press release relate
to our future plans, objectives, expectations and intentions and
include, but are not limited to, those relating to our ability to
borrow under the March 2005 $15.0 million convertible line of credit,
those by Robert J. Sutcliffe, other statements about the timing,
commencement and parameters of the confirmatory Phase III clinical
trial in Europe and statements relating to our expectation and the
timing of amending our NDA filing. Our actual results may differ
materially from those described in these statements. For instance, the
occurrence of one or more of the following may cause our results to
differ from our plans: our operating capital may not be sufficient to
continue some or all of our development programs, we may be unable to
borrow under the March 2005 $15.0 million credit line; we may be
unable to complete the PHOTREX(TM) confirmatory Phase III clinical
trial; we may be unable to complete the NDA review process or continue
as a going concern; we may not meet the covenants of the December 2002
Debt Agreement or the August 2003 Convertible Debt and Warrant
Purchase Agreement, which would give the holders under these
agreements the right to call outstanding debt immediately due and
payable; we may not achieve certain milestones required to receive
future investments under our Collaboration Agreement with Guidant
Corporation; we may be unable to resolve all issues or contingencies
associated with the NDA; the FDA may require further clinical or
non-clinical studies before granting PHOTREX(TM) marketing approval,
or may limit labeling claims, or may not grant marketing approval at
all; even if approved, we may not have the necessary resources or
corporate partnering relationship(s) to commercialize PHOTREX(TM) and
its degree of acceptance cannot be guaranteed; we may decide not to or
may be unable to continue the Company's current development programs;
we may not be able to demonstrate the safety or efficacy of our drugs
in development or achieve their regulatory approvals; and/or
partnering discussions may not progress or may not provide the funding
and support the Company needs. For a discussion of additional
important risk factors that may cause our results to differ from those
described above, please refer to our annual report on Form 10-K for
the year ended December 31, 2004 and other quarterly and periodic
reports filed with the Securities and Exchange Commission. Our
products require regulatory approval before marketing, sales or
clinical use. PhotoPoint(R) is a registered trademark of Miravant
Medical Technologies. PHOTREX(TM) is a trademark of Miravant Medical
Technologies.
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Miravant Medical Technologies
Condensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2005 2004 2005 2004
------------ ------------ ------------- -------------
Revenues $-- $-- $-- $--
Costs and
expenses:
Research and
development 2,050,000 1,862,000 7,177,000 5,769,000
General and
administrative 964,000 1,144,000 3,562,000 4,456,000
------------------------- ---------------------------
Total costs and
expenses 3,014,000 3,006,000 10,739,000 10,225,000
Loss from
operations (3,014,000) (3,006,000) (10,739,000) (10,225,000)
Other income
(expense):
Interest and
other income 74,000 36,000 171,000 80,000
Interest expense (547,000) (511,000) (1,545,000) (2,567,000)
Gain on sale of
property, plant
and equipment 1,000 37,000 33,000 72,000
------------------------- ---------------------------
Total other
expenses (471,000) (438,000) (1,341,000) (2,415,000)
------------------------- ---------------------------
Net loss $(3,485,000) $(3,444,000) $(12,080,000) $(12,640,000)
============ ============ ============= =============
Net loss per
share - basic
and diluted $(0.09) $(0.10) $(0.32) $(0.40)
============ ============ ============= =============
Shares used in
computing net
loss per
share 37,511,524 35,261,531 37,237,312 31,866,397
============ ============ ============= =============
Selected Consolidated
Balance Sheet Data
As of As of
9/30/05 12/31/04
(unaudited)
Cash, cash equivalents and marketable
securities $3,863,000 $6,099,000
Total current assets 4,431,000 6,413,000
Total assets 5,731,000 7,509,000
------------ ------------
Total current liabilities $6,132,000 $1,858,000
Total long-term liabilities 4,434,000 7,633,000
Total stockholders' equity (deficit) (4,835,000) (1,982,000)
Total liabilities and stockholders' equity
(deficit) $5,731,000 $7,509,000
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