MolMed Board of Directors Approves the Interim Financial Report at 31 March 2012
- Progress of pivotal Phase III trials of TK for the treatment of high-risk leukaemia and NGR-hTNF for the treatment of malignant pleural mesothelioma - Revenues from services to third parties up 166%
(firmenpresse) - MILAN, ITALY -- (Marketwire) -- 05/14/12 -- The Board of Directors of MolMed S.p.A. (MILAN: MLM), chaired by Professor Claudio Bordignon, today reviewed and approved the interim financial report at 31 March 2012.
Claudio Bordignon, Chairman and CEO of MolMed, commented: "In this first quarter we achieved important results, by advancing the clinical development of our investigational products and validating our know-how in cell and gene therapy. The pivotal Phase III trials for TK and NGR-hTNF are progressing. In particular, the patient recruitment rate in the NGR-hTNF trial for mesothelioma accelerated, bringing the trial population enrolled so far to 200 patients, over half of the foreseen total. Regarding GMP production for third parties, the agreements signed in 2011 are now producing tangible economic effects, which are reasonably expected to continue throughout the year; above all, I think that our platform in gene therapy is increasingly becoming a technology asset that could provide additional strategic opportunities."
KEY ACHIEVEMENTS IN THE FIRST QUARTER OF 2012
Research & Development activities
In the first quarter of 2012, MolMed pursued the clinical development of its investigational anticancer products, TK for the treatment of high-risk leukaemia and NGR-hTNF for the treatment of different types of solid tumours.
Regarding the pivotal Phase III trial (TK008) in Europe, it is foreseen to involve additional centres above the 15 originally planned. The trial is currently ongoing in 7 clinical centres in Europe, namely Italy, Spain, Greece and Germany, and is about to be expanded to 10 additional centres in the following countries: Belgium, France, Germany, Israel, the Netherlands and the US.
For NGR-hTNF, major progress included:
Development and GMP production for third parties
The successful development and GMP production of novel gene therapy treatments for third parties confirms the Company's technological leadership in this field, while generating a significant increase in revenues (see income statement on full version of press release). During the first three months of 2012, work continued under two major agreements signed in 2011, respectively with Telethon Foundation and GlaxoSmithKline, for the development and production of highly innovative investigational gene therapy treatments for a total of seven rare genetic diseases.
SUMMARY ON FINANCIAL RESULTS
MolMed's financials are peculiar to the business model of biotech companies focused on R&D of new biopharmaceutical products and with no products on the market. At this stage high costs must be sustained for the clinical and pharmaceutical development of investigational therapeutics, whose return is deferred to future years. In addition, given the Company's operating activities and the characteristics of trials conducted, research and development costs are fully recorded in the period they are incurred.
Operating revenues totalled EUR 1.2 million at 31 March 2012, an increase of 103.6% compared to the first quarter of 2011. The sharp increase in revenues is due to the intensification of development and GMP production activities for third parties: these revenues rose by 166.1%, from EUR 0.4 million in the first quarter of 2011 to EUR 1.1 million in the first quarter of 2012.
In the first quarter of 2012, operating costs totalled EUR 6.3 million, up 14.2% compared to the first quarter of 2011. The increase is due to an intensification of costs related to the progress of clinical trials of NGR-hTNF and to its industrial manufacturing process, as well as to the intensification of costs related to the increase of development and GMP production activities for third parties.
The operating loss for the first quarter of 2012 was of EUR 5.1 million, up 3.8% compared to the first quarter of 2011. This is due to the expected increase in operating costs resulting from the intensification of development activities for MolMed's investigational therapeutics.
Financial income rose from EUR 219,000 in the first quarter of 2011 to EUR 250,000 in the first quarter of 2012, as a result of the management of financial resources through temporary, low-risk investments.
The net result for the first quarter of 2012 recorded a loss of EUR 4.9 million, compared to a loss of EUR 4.7 million in the first quarter of 2011.
The net financial position at 31 March 2012 totalled EUR 33.0 million, and included cash on hand, other cash and cash equivalents of EUR 11.4 million, and investment in current assets of EUR 21.8 million, net of EUR 0.2 million for lease payables due to the accounting of lease contracts for lab equipment.
The official Corporate Financial Reporting Manager of MolMed S.p.A., Enrico Cappelli, herewith attests, pursuant to Article 154-bis, paragraph 2 of the Italian Consolidated Law on Finance (Legislative Decree 58/1998), that the accounting disclosure contained in this press release matches documentary evidence, corporate books, and accounting records.
In this press release, use is made of "alternative performance indicators" which are not provided for under European IFRS, and whose significance and content - in line with Recommendation CESR/05-178b published on November 3, 2005 - are illustrated below:
This press release is written in compliance with public disclosure obligations established by CONSOB (Italian securities & exchange commission) resolution no. 11971 of 14.5.1999, as subsequently amended.
About MolMed
MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel antitumour therapies. MolMed's pipeline includes two novel therapeutics in clinical development: TK, a cell- based therapy enabling bone marrow transplants from partially compatible donors, in Phase III in high-risk acute leukaemia; NGR-hTNF, a novel vascular targeting agent (VTA), in Phase III in malignant pleural mesothelioma and in Phase II in six more indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas. MolMed also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate projects from preclinical to Phase III trials, including scale-up and cGMP production of clinical-grade viral vectors, and manufacturing of patient-specific genetically engineered cells. MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The Company's shares are listed on the Milan Stock Exchange, at the Standard segment (class I) of the MTA managed by Borsa Italiana. (Ticker Reuters: MLMD.MI).
DISCLAIMER
This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The Company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of MolMed S.p.A.
FULL VERSION OF PRESS RELEASE AVAILABLE ON MOLMED WEBSITE ().
Contacts:
Investor Relations: MolMed S.p.A.
Holger Neecke
Director Business Development & Investor Relations
+39 02 21277.205
+39 02 21277.325 (FAX)
Administration, Finance and Control: MolMed S.p.A.
Enrico Cappelli
Chief Financial Officer
+39 02 21277.302
+39 02 21277.325 (FAX)
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Datum: 14.05.2012 - 17:09 Uhr
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