16.05.2005 15:06:00

Miravant Announces First Quarter Results for 2005

Miravant Announces First Quarter Results for 2005


    Business Editors/Health/Medical Writers

    SANTA BARBARA, Calif.--(BUSINESS WIRE)--May 16, 2005--Miravant Medical Technologies (OTCBB:MRVT), a pharmaceutical development company specializing in PhotoPoint(R) photodynamic therapy (PDT), announced consolidated financial results for the first quarter ended March 31, 2005. The net loss for the quarter was $3.7 million or ($0.10) per share, compared to a net loss of $5.5 million, or ($0.20) per share, for the same period in 2004.
    The Company had cash of $3.2 million at March 31, 2005. Subsequent to the end of the quarter on May 4, 2005, the Company completed a private placement led by Scorpion Capital Partners resulting in net proceeds to the Company of approximately $7.5 million. These funds, together with the previously announced $15.0 million convertible debt line-of-credit, provide Miravant with approximately $25.0 million in cash for operations, subject to certain conditions.
    Gary S. Kledzik, Ph.D., chairman and chief executive officer, stated, "We were pleased to make several important announcements during the first quarter, including details about the conduct and timing of the confirmatory Phase III clinical trial for PHOTREX(TM), which is expected to begin this summer. Our recently completed financings will provide support for the confirmatory clinical trial. Miravant also welcomed accomplished new members to its board of directors."

    Financings

    In March 2005, Miravant announced the completion of a convertible debt line-of-credit that will enable the Company to borrow up to $15.0 million, subject to certain conditions. The funds will be available at the Company's discretion in increments of up to $1.0 million per month, with any unused monthly borrowings to be carried forward. Each borrowing will be represented by a convertible note and a warrant to purchase one-quarter of a share of Common Stock for each share of Common Stock underlying the convertible note. Subsequent to the end of the quarter, this funding was amended to specify the minimum conversion rate of $1.00 per share of convertible Common Stock or 125% of the average monthly closing price of the month preceding the conversion, whichever is greater.
    In May 2005, Miravant completed an $8.0 million convertible preferred stock funding, with net proceeds to the Company of approximately $7.5 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.

    PHOTREX(TM) Confirmatory Clinical Trial

    During the first quarter Miravant announced its plans to conduct a confirmatory Phase III clinical trial for PHOTREX(TM) at approximately 50 investigational sites in the United Kingdom, Central and Eastern Europe (CEE). Miravant appointed Kendle, an international contract research organization, to provide clinical development and trial management services for the clinical study, currently planned to commence in mid-2005. 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, 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 2004, after reviewing the Company's New Drug Application (NDA).

    Board of Directors

    In January 2005, Miravant announced the elections of Robert J. Sutcliffe and Michael Khoury to its board of directors. After the close of the quarter, in May 2005, the Company also announced the elections to its board of directors of Nuno Brandolini, Kevin R. McCarthy and Rani Aliahmad.

    About Miravant

    Miravant Medical Technologies specializes in PhotoPoint(R) photodynamic therapy (PDT), developing photoreactive (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 program, 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 MV0633 in advanced preclinical testing for atherosclerosis, vulnerable plaque and restenosis.
    For more information, please visit our web site at: www.miravant.com.

    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 Dr. Kledzik, and other statements about the timing and commencement of the confirmatory Phase III clinical trial in Europe; selection of Kendle to manage this study; plans to conduct a primary endpoint analysis at twelve months of approximately 650 patients; amending our NDA and seeking regulatory approval of PHOTREX; plans to initiate a clinical study to investigate the use of PHOTREX in combination with other AMD therapies; 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 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, the August 2003 Convertible Debt and Warrant Purchase Agreement, or the March 2005 Note 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 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 appointment of Kendle is subject to the completion of the final contract; 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 drugs in ophthalmology, dermatology, cardiovascular disease and/or oncology; 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.

MIRAVANT MEDICAL TECHNOLOGIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

Three months ended March 31, --------------------------- 2005 2004 ---------------------------

Revenues $-- $--

Costs and expenses: Research and development 1,852,000 2,261,000 General and administrative 1,450,000 1,724,000 ------------ ------------ Total costs and expenses 3,302,000 3,985,000

Loss from operations (3,302,000) (3,985,000)

Interest and other income (expense): Interest and other income 41,000 20,000 Interest expense (477,000) (1,538,000) Gain on sale of assets 28,000 9,000 ------------ ------------ Total net interest and other expense (408,000) (1,509,000) ------------ ------------

Net loss $(3,710,000) $(5,494,000) ============ ============ Net loss per share - basic and diluted $(0.10) $(0.20) ============ ============ Shares used in computing net loss per share 36,938,937 27,251,824 ============ ============

Selected Consolidated Balance Sheet Data As of As of 3/31/05 12/31/04 (unaudited) Cash, cash equivalents and marketable securities $3,175,000 $6,099,000 Total current assets 3,353,000 6,413,000 Total assets 4,474,000 7,509,000 ----------- -----------

Total current liabilities $1,875,000 $1,858,000 Total liabilities 9,770,000 9,491,000 Total stockholders' equity (deficit) (5,296,000) (1,982,000) Total liabilities and stockholders' equity (deficit) 4,474,000 7,509,000



--30--LK/at*

CONTACT: Miravant Medical Technologies John Philpott, Chief Financial Officer 805-685-9880 Tom Herrick, Investor Relations 805-685-9880 www.miravant.com

KEYWORD: CALIFORNIA INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL EARNINGS SOURCE: Miravant Medical Technologies

Copyright Business Wire 2005

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