Cardio3 BioSciences to Enroll the 120th Patient for Its Chart-1 Study

Cardio3 Biosciences (C3BS) (Paris:CARD) (Brussels:CARD) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of advanced regenerative therapies for heart disease, announces today that it has enrolled the 120^th patient in its phase III clinical study CHART-1, aimed at evaluating the potential of its product candidate C-Cure® for the treatment of heart failure. This represents the half of patients to be recruited into CHART-1.

With over 25 active centers in 10 countries, the Company is in line with its goal of completing the recruitment of all patients by the end of 2014.

CHART-1 is a prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded study comparing treatment with C-Cure® to a sham treatment. The trial will recruit a minimum of 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at 9 months post-procedure. This study represents the world’s first Phase III trial for a pre-programmed cellular therapy targeting heart failure.

To date, no incidents reported in the study call into question the continuation thereof. The safety analysis during the third quarter and futility analysis around the end of this year are the next steps in the study.

Dr Christian Homsy, CEO of Cardio3 BioSciences, comments: "We are very pleased to announce the recruitment of the 120^th patient that keeps us on target with our goal of enrolment. This is an important milestone that demonstrates the momentum seen into the start of 2014. Everyday, thanks to the commitment of our teams and clinical centers that combine enthusiasm and competence, we are coming closer to our goal which is to bring a totally new and different treatment to thousands of patients suffering from heart failure."

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About Cardio3 BioSciences

Cardio3 BioSciences is a Belgian leading biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases. The company was founded in 2007 and is based in the Walloon region of Belgium. Cardio3 BioSciences leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Centre Aalst, Belgium.

The Company’s lead product candidate C-Cure® is an innovative pharmaceutical product that is being developed for heart failure indication. C-Cure® consists of a patient’s own cells that are harvested from the patient’s bone marrow and engineered to become new heart muscle. This process is known as Cardiopoiesis.

Cardio3 BioSciences has also developed C-Cath®_ez, the most technologically advanced injection catheter with superior efficiency of delivery of bio therapeutic agents into the myocardium.

Cardio3 BioSciences’ shares are listed on Euronext Brussels and Euronext Paris under the ticker symbol CARD.

C3BS-CQR-1, C-Cure, C-Cath, Cardio3 BioSciences and the Cardio3 BioSciences and C-Cath logos are trademarks or registered trademarks of Cardio3 BioSciences SA, in Belgium, other countries, or both. Mayo Clinic holds equity in Cardio3 BioSciences as a result of intellectual property licensed to the company. In addition to historical facts or statements of current condition, this press release contains forward-looking statements, which reflect our current expectations and projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. These forward-looking statements are further qualified by important factors, which could cause actual results to differ materially from those in the forward-looking statements, including timely submission and approval of anticipated regulatory filings; the successful initiation and completion of required Phase III studies; additional clinical results validating the use of adult autologous stem cells to treat heart failure; satisfaction of regulatory and other requirements; and actions of regulatory bodies and other governmental authorities.