LipoNova AG reaches important milestones in Q3
for the further development of Reniale
Equity ratio at approx. 90 percent
Hannover, Germany. 7th November 2007 – In Q3 of 2007, Phase-III biotech company LipoNova AG (WKN LNAG00) reached important milestones in the development of its product candidate Reniale. This success is reflected in the company’s positive balance. After a successful consultation with the U.S. Food and Drugs Administration (FDA), LipoNova may be granted FDA approval to market Reniale(R) in the U.S. after completing a successful Phase-III study, without needing to undertake further studies. In addition, LipoNova may be able to renew its production license for Reniale(R) in the near future.
During Q3 2007, LipoNova continued to focus on driving the development of Reniale(R). Accordingly, the company’s turnover remained at ten thousand euros in this quarter, as opposed to four thousand euros in Q3 2006. The net loss for Q3 of -3.1 million euros was affected significantly by regulatory expenses and met the company’s expectations. In Q3 2006, the net loss was -2.2 million euros. At 90 percent, the company’s equity ratio as of September 30, 2007 almost equaled that of December 2006.
During the next quarters, LipoNova will continue to implement the measures it has already initiated. These include introducing Reniale(R) into non-European foreign markets, starting the named patient programs, securing the company’s financial situation and most importantly, launching the Phase-III study. LipoNova’s executive board is confident that the company will continue to succeed by fulfilling these objectives.
LipoNova is developing an effective therapy for non-metastatic renal cell carcinoma (RCC), a serious disease with high unmet medical need and we are pioneers in the development of autologous tumour vaccines, a new class of compounds for combating diseases of this type. We have successfully completed a Phase-III clinical study on adjuvant RCC with Reniale(R) our lead product, the world’s first autologous treatment with proven efficacy and safety as an adjuvant therapy in non-metastatic RCC.
LipoNova is well positioned to bring Reniale(R) to market with an international Phase III study planned to start 2008 and as this progresses, it will also expand its oncology franchise in the short to medium term through partnering, mergers and acquisitions.