BioCardia (BCDA) Update on Cell Therapy Product Development and 2021 Milestones

BioCardia®, Inc. (Nasdaq: BCDA) a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today provides an update on its cell therapy product development and 2021 milestones.

• BCDA-01, our CardiAMP autologous cell therapy under Phase III clinical development for the treatment of ischemic heart failure remains the Company’s top priority. The Company is targeting completion of enrollment without requiring additional financing. The trial is expected to have its next prespecified independent Data Safety Monitoring Board review in early Q3 2021.
• BCDA-02, our CardiAMP autologous cell therapy is under Phase III development for the treatment of chronic myocardial ischemia. First patient enrolled in the trial is expected in Q1 with roll in cohort safety data in 2021.
• BCDA-03, our allogenic neurokinin 1 receptor positive (NK1R+) Mesenchymal Stem Cell (MSC) Phase I/II program follows previous Phase I/II clinical development work with MSCs for the treatment of ischemic heart failure and is intended initially for those patients excluded from BCDA-01. In recent Investigational New Drug (IND) application submission interactions for this program, the FDA has indicated comfort regarding the pharmacology and toxicology and with the clinical plan but had continued questions related to our chemistry, manufacturing, and controls (CMC). We are working to resolve the outstanding issues with the agency to enable us to move forward with the NK1R+ MSC program and target IND acceptance in 2021.
• BCDA-04, our allogenic NK1R+ MSC Phase I/II program for the treatment of acute respiratory distress resulting from COVID-19 is on a similar timeline to our BCDA-03 program as it utilizes substantially the same CMC. New strains of COVID-19 may enhance the importance of this therapeutic program and we target IND acceptance in 2021.

“This is a big year ahead for BioCardia as we advance our two pivotal autologous cell therapy cardiac programs and ramp manufacturing activities for our allogenic cell therapy programs,” said Peter Altman, Ph.D., BioCardia’s CEO. “Recent results in the field have enhanced recognition for our technological and strategic approach to autologous cardiac cell therapy with the CardiAMP Cell Potency Assay to reduce patient variability, trial designs targeting patient populations sick enough to benefit greatly but not so ill that comorbidities drive outcomes, and the use of our leading Helix transendocardial biotherapeutic delivery system for enhanced dosage efficiency. The Helix system, used in all three of our cardiac programs, is also anticipated to see greater usage by partners in the year ahead.”

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