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 second quarter ended June 30, 2005. The net loss for the
quarter was $4.9 million or ($0.13) per share, compared to a net loss
of $3.7 million, or ($0.11) per share, for the same period in 2004.
The net loss for the six months ended June 30, 2005 was $8.6 million
or ($0.23) per share, compared to a net loss of $9.2 million or
($0.30) per share, for the same period in 2004.
The Company had cash and marketable securities of $7.5 million at
June 30, 2005. The Company also has a $15.0 million convertible line
of credit available to the Company under certain conditions and
restrictions.
"Miravant's board and employees are focused on preparation and
launch of the confirmatory Phase III clinical trial for PHOTREX for
the treatment of wet age-related macular degeneration. Patient
screening for the confirmatory Phase III clinical trial is underway
and patient treatment is scheduled to begin within the next 30 days at
multiple trial venues," stated Robert J. Sutcliffe, Miravant's
chairman. "While focusing the company's efforts on this important
trial, we have been able to realize significant expense reductions
through a company-wide restructuring program, and we continue to
assess valuation enhancement opportunities presented by our companion
programs. We are gratified by the response to the progress in our
programs and our PhotoPoint technology and we look forward to building
on that progress with the restructured Miravant."
PHOTREX(TM) Confirmatory Clinical Trial
The confirmatory Phase III clinical trial for PHOTREX(TM) is
expected to commence during the third quarter of 2005 at approximately
50 investigational sites in the United Kingdom, Central and Eastern
Europe (CEE). The randomized, placebo-controlled trial, reviewed by
the U.S. Food and Drug Administration (FDA) under a Special Protocol
Assessment, will include a range of patients with both classic and
occult forms of wet age-related macular degeneration (AMD).
Miravant also disclosed that it expects to conduct a primary
efficacy endpoint analysis at 12 months (one year after initial
treatment), with a total of approximately 650 patients to be analyzed.
Assuming the achievement of positive clinical results, the Company
expects to amend its New Drug Application (NDA) to seek marketing
approval while the patients are followed for a second year.
PHOTREX(TM), Miravant's most advanced PDT drug, is in development
to treat patients with wet AMD, a debilitating eye disease and leading
cause of blindness in older adults. The FDA requested the confirmatory
Phase III study in its Approvable Letter dated September 30, 2004,
after reviewing the Company's New Drug Application (NDA).
Financings
In May 2005, Miravant completed an $8.0 million convertible
preferred stock funding, with net proceeds to the Company of
approximately $7.6 million. The Preferred Stock is convertible into
Common Stock at the conversion price of $1.00 per share. The Company
also issued a warrant to purchase one share of Common Stock for each
convertible share of Common Stock purchased. The exercise price of
each warrant is $1.00 per share.
Other Events
On June 23, 2005, the Company held its Annual Meeting of
Stockholders and following individuals were elected to the Board of
Directors: Rani Aliahmad, Nuno Brandolini, Michael Khoury, Gary S.
Kledzik, David E. Mai, Kevin R. McCarthy and Robert J. Sutcliffe.
In July 2005, the Company implemented a significant cost
restructuring program. This cost restructuring program included a
detailed evaluation of all of the Company's research and operating
costs. Based on the results of this evaluation, the Board of Directors
concluded that a reduction in staff was necessary, as well as overall
salary decrease for some of the remaining employees and executives.
In addition, the Board of Directors also accepted the resignation
of Gary S. Kledzik, Ph.D. as chief executive officer, chairman and
director. The 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. Miravant's
President, David E. Mai and CFO, John M. Philpott, will report to the
interim executive committee.
About Miravant
Miravant Medical Technologies 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 Special Protocol Assessment for a 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(R) 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,
including but not limited to those by Robert J. Sutcliffe, and other
statements about the timing and commencement of the confirmatory Phase
III clinical trial in Europe; plans to conduct a primary endpoint
analysis at twelve months of approximately 650 patients; amending our
NDA and seeking regulatory approval of PHOTREX; and development
programs in ophthalmology and cardiovascular disease are
forward-looking and relate to our future plans, objectives,
expectations and intentions. 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, complete the PHOTREX
confirmatory Phase III clinical trial, 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 be able to continue to borrow under the March 2005
Debt Agreement, which provides that the lenders' obligations are
subject to certain conditions; the impact of the recent cost
restructuring program may not be sufficient and we may be required to
further scale back our operating costs; 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 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 and its degree of acceptance cannot be
guaranteed; the FDA may not permit us to commence human clinical
trials in cardiovascular disease; we may decide not to or may be
unable to further develop our PhotoPoint(R) drugs in ophthalmology and
cardiovascular disease; 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 Six Months Ended
June 30, June 30, June 30, June 30,
2005 2004 2005 2004
------------ ------------ ------------ ------------
Revenues $ -- $ -- $ -- $ --
Costs and expenses:
Research and
development 3,275,000 1,647,000 5,127,000 3,908,000
General and
administrative 1,148,000 1,587,000 2,598,000 3,311,000
------------ ----------- ------------ -----------
Total costs and
expenses 4,423,000 3,234,000 7,725,000 7,219,000
Loss from
operations (4,423,000) (3,234,000) (7,725,000) (7,219,000)
Other income
(expense):
Interest and
other income 56,000 24,000 97,000 44,000
Interest expense (522,000) (517,000) (999,000) (2,056,000)
Gain on sale of
property, plant
and equipment 4,000 26,000 32,000 35,000
------------ ----------- ------------ -----------
Total other income
(expense) (462,000) (467,000) (870,000) (1,977,000)
------------ ----------- ------------ -----------
Net loss $(4,885,000) $(3,701,000) $(8,595,000) $(9,196,000)
=========== =========== =========== ===========
Net loss per share -
basic and diluted (0.13) (0.11) (0.23) (0.30)
=========== =========== =========== ===========
Shares used in
computing net loss
per share 37,254,508 33,048,546 37,097,594 30,158,452
============ =========== =========== ===========
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Selected Consolidated
Balance Sheet Data
As of As of
6/30/05 12/31/04
(unaudited)
Cash, cash equivalents and marketable
securities $ 7,511,000 $ 6,099,000
Total current assets 7,569,000 6,413,000
Total assets 8,890,000 7,509,000
----------- -----------
Total current liabilities $ 2,982,000 $ 1,858,000
Total liabilities 10,427,000 9,491,000
Total stockholders' equity (deficit) (1,537,000) (1,982,000)
Total liabilities and stockholders' equity
(deficit) 8,890,000 7,509,000
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