C3BS plans to open new U.S.-based facility to manufacture C-Cure for use in Phase III trial

Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of engineered cell therapies, today confirmed plans to open a new U.S.-based manufacturing facility in Rochester, Minnesota. The facility will support the Company’s current and anticipated manufacturing needs in the United States for both the Phase III clinical trial evaluating lead cardiovascular product candidate C-Cure^® (CHART-2), and its recently acquired CAR T-cell therapies’ portfolio. The facility will also serve as a base for the Company’s research and clinical collaboration with Mayo Clinic, also based in Rochester.

C-Cure^® is an autologous cellular therapy for the treatment of congestive heart failure that is based on the Company’s proprietary Cardiopoiesis platform, initially developed using fundamental research and proprietary technology from the Mayo Clinic.

The 11,000-square-foot (approximately 1,000 square meters) facility is located in the Minnesota Bio Business Center in downtown Rochester and will initially primarily be used to manufacture C-Cure^® for use in CHART-2, the U.S. Phase III trial.

Cardio3 BioSciences will receive non-dilutive funding from The Minnesota Department of Employment and Economic Development (DEED) and the Minnesota Job Creation Fund once it completes its investment and hiring goals.

Christian Homsy, CEO of Cardio3 BioSciences, commented:

We are very thankful to Rochester, RAEDI and DEED for the efforts that they made in facilitating the public assistance and location for our facility. Our plans for this facility will first be to manage the manufacturing-related activities associated with the U.S. portion of CHART-2, our second global Phase III clinical trial for C-Cure^®.

City of Rochester Mayor Ardell Brede, remarked:

Initially a result of our city’s attendance at the annual Bio International Trade Shows, this project has been seven years in the making and we are proud to see our relationship with Cardio3 BioSciences blossom with the Company’s commitment to further establish its presence in our city. Cardio3 BioSciences will be an important component of our business community and we look forward to supporting their goals of continued development of a novel cellular therapy that has the potential to treat patients who suffer from congestive heart failure.

RAEDI President Gary Smith, said:

Securing Cardio3 BioSciences’ newest U.S. location in Rochester is the result of an expansive effort led by Rochester Area Economic Development, the City of Rochester, Mayo Clinic, and the Minnesota Department of Employment and Economic Development, and we appreciate all who championed the endeavour. Cardio3 BioSciences will anchor our area’s emerging Regenerative Medicine Cluster with its focus on developing leading cellular therapies, and we encourage members of the community to welcome the Company.

Cardio3 BioSciences, headquartered in Mont-Saint-Guibert, Belgium, was founded in 2007 with a focus on discovering, developing and commercializing cell-therapy treatments with clinical programs initially targeting indications in cardiovascular disease and oncology. The Company’s C-Cure^® therapy involves taking stem cells from a patient’s own bone marrow and through a proprietary process called Cardiopoiesis, reprogramming them to repair that patient’s damaged heart muscle.

DEED Commissioner Katie Clark Sieben, noted:

Cardio3 BioSciences is a global Company developing innovative heart therapy treatments, and is a welcome addition to a world-leading destination for life sciences. The Company’s choice to invest in Rochester and more broadly, Minnesota, will mean positive economic benefits for the community, including new, high-quality jobs.