Mont-Saint-Guibert, Belgium –The biotechnology company, Cardio3 BioSciences SA (“Cardio3” or the “Company”), 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 financial results for the six-month period ending 30 June 2013.
- Cardio3 initiated the CHART-1 clinical trial of its lead product candidate, C-Cure®. This is the world’s first Phase III clinical trial of a regenerative medicine for the treatment of heart failure. First patients were treated in June 2013.
- In April 2013, the results of the Phase II study of C-Cure®, completed in January 2012, were published in the Journal of the American College of Cardiology (JACC). The publication reported a significant improvement in treated patients.
- In May, Cardio3 completed a €19.0 million capital increase through a contribution in kind of shareholders’ debt for €12.0 million and new cash for €7.0 million.
- In June, Cardio3 announced its intention to raise additional funding through an Initial Public Offering on NYSE Euronext Brussels and NYSE Euronext Paris. The IPO was successfully closed in early July with a total of €26.5 million raised.
Dr Christian Homsy, CEO of Cardio3 BioSciences, said: “Since the beginning of 2013 Cardio3 has achieved several important milestones to extend its leadership in regenerative medicine for the treatment of heart failure. In receiving approval in several European countries for our CHART-1 trial we have advanced the development of our lead candidate, C-Cure®, a unique therapy which we believe could represent a significant step forward in the treatment of heart failure. We have also successfully raised the funds needed to take the CHART-1 trial through to completion and this places us in a very strong position.”
Initiation of CHART-1 trial
Cardio3 is developing its most advanced therapy, C-Cure®, for the treatment of heart failure, one of the world’s greatest unmet medical needs. During the first half of 2013, Cardio3 received approval from several European competent authorities for the initiation of the CHART-1 (Congestive Heart failure Cardiopoietic Regenerative Therapy) trial following authorization from the Belgian Ministry of Health received at the end of November 2012. This is the world’s first Phase III clinical trial of a regenerative medicine for the treatment of heart failure.
As of 30 June 2013, the CHART-1 trial was approved in Belgium, UK, Serbia, Hungary and Israel. First patients were treated in the trial at the CHU Charleroi, Belgium.
The Company is actively working with authorities of other EU countries to secure approval to treat patients in additional geographies. As of June 30th, the Company was on target for its patient enrolment with the goal to complete enrolment in CHART-1 by the end of 2014.
Publication of C-Cure Phase II data in JACC
In April 2013, the Phase II data of the C-Cure trial completed in January 2012 were published in the Journal of American College of Cardiology (JACC). The publication reported statistically significant improvement in cardiac function and exercise capacity of the treated patients.
Cardio3 BioSciences has two additional programs in its R&D pipeline beyond C-Cure®, both noncellular therapeutic programs in development for the treatment of acute myocardial infarction (AMI) or “heart attack”. GQR-1 is a protein-based product candidate for myocardial regeneration comprising a group of proteins. Previous preliminary preclinical studies have showed very encouraging data in large animals in a model of AMI. Additional GLP preclinical studies will soon be initiated aiming at preparing GQR-1 for a first in man trial by end of 2014. GQR-4 is an early stage preclinical protein based product candidate for the prevention of warm reperfusion injury. GQR-4 will soon be tested in-vivo in an ischemia reperfusion injury animal model.
Corporate and Financial Review
At the end of May 2013, Cardio3 successfully completed a €19.0 million capital increase through a contribution in kind of shareholders debt for €12.0 million and new cash for €7.0 million.
In June 2013, the Company announced its intention to raise additional funding through an Initial Public Offering on NYSE Euronext Brussels and NYSE Euronext Paris. The IPO was successfully closed in early July 2013 with a total of €26.5 million raised. The proceeds of the IPO are intended to secure operations of the Company until the readout of the primary endpoint of the CHART-1 clinical trial.
As at June 30, 2013 Cardio3 had €3.9 million in cash and cash equivalents compared to €1.6 million at 31 December 2012.
For the six month period ending 30 June 2013, total operating expenses of the Company amounted to €5.2 million compared to €6.2 million for the same period in 2012.
In the first six months of 2013, the loss from operations before interest and taxes was €6.0 million versus €6.5 million in the first half of 2012. The net loss for period was €6.4 million versus a net loss of €6.7 million for same period in 2012.
The complete “Half-year Financial Report” is available on the company’s website.
Conference call details
The company will host a conference call to present its 2013 half year financial results on Wednesday August 28, 2013 at 2:00 pm CET – 1:00 pm UK – 8:00 am EST.
Dial in numbers: International +44 (0) 1452 555566 / UK 08444933800 / Belgium 081700061 / France 0176742428 / USA 16315107498. Conference ID: 43157826 Access to the conference call 10 minutes prior to its start time