Mont-Saint-Guibert, Belgium – Cardio3 BioSciences SA (C3BS) (NYSE Euronext Brussels and Paris: CARD), a leader in the discovery and development of regenerative, protective and reconstructive therapies for the treatment of cardiac diseases, today announces a business update and its consolidated financial results for the six-month period ending 30 June 2014 prepared in accordance with IFRS as endorsed by the European Union.
Operational highlights
• Continued progress with the CHART-1 clinical trial of its lead product candidate, C-Cure®
o To date, ten countries have granted authorization for CHART-1
o On course for completion of enrolment towards year end 2014
o EMA has granted Certification of Quality Data for C-Cure®
• FDA clearance to initiate CHART-2, the second phase III trial of C-Cure®
o IND from the FDA delivered in January 2014
• Business Development Strategy confirmed at the end of 2013 strengthened by the appointment of Georges Rawadi as Vice President Business Development
• Strengthening of the operational capabilities of the Company in anticipation of commercial launch through the appointment of Hanspeter Spek, former President Global Operations at Sanofi, as independent director of the Company
• Cardio3 BioSciences’ advanced technologies featured in two top tier scientific publications
• IP Portfolio strengthened with new US Patent
• First sales contract for C-Cathez®
Financial highlights
• Strong cash position with €40.1 million in cash and term deposits as of 30 June 2014, sufficient to finance the Company’s existing clinical development program
• Completion of a capital increase of €25.0 million in June 2014 at €44 per share, a 14% premium to the 30 days average of the Company’s shares, fully subscribed by Medisun International, and providing funding to conduct the CHART-2 clinical trial for C-Cure®
• Joint venture agreement with Medisun International to create Cardio3 BioSciences Asia Holdings Ltd, a Joint Venture aimed at conducting pivotal clinical programs in Greater China
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “Our half year financial results confirm Cardio3 BioSciences is firmly set on a good course: our finances are sound and our operations are delivering to plan. Our teams and clinical centers are, more than ever, committed to bringing innovative and ground-breaking solutions for the many patients suffering from heart failure and other cardiac diseases. With our clinical trials evolving as planned, and with our strict cash management, we can look towards more positive results and a promising future.”
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