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 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. -0- *T 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 ============ =========== =========== =========== ---------------------------------------------------------------------- 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 ---------------------------------------------------------------------- *T