MRVT Miravant Medical Technologies (CE)

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. -0- *T 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 *T