H.C Wainwright initiated coverage of BioCardia (NASDAQ:BCDA) with a “buy” rating and price target of $9. The stock closed at $1.71 on Dec. 17.
BioCardia is a clinical-stage company focused on the development of cell therapies for the treatment of cardiovascular diseases.
BioCardia’s CardiAMP Cell Therapy System is designed to provide two autologous bone marrow derived cell therapies, BCDA-01 and BCDA-02, currently being investigated in two randomized, placebo controlled pivotal trials targeting heart failure post myocardial infarction (CardiAMP HF) and patients with no option chronic myocardial ischemia with refractory angina or RA (CardiAMP CMI), respectively.
Analyst Emanuela Branchetti, Ph.D., writes that unique to BioCardia’s CardiAMP platform is a proprietary potency assay used for the screening of a patient’s bone marrow cells and used to identify those patients most likely to respond to therapy ahead of treatment; and a proprietary FDA-cleared and CE Marked device, the CardiAMP System and Helix catheter, to process and deliver therapeutic doses to the myocardium in a minimally invasive setting.
CardiAMP HF is currently ongoing with 106 patients enrolled as of a third quarter update of a 260 target, across 24 active sites in the U.S., and with additional sites being activated, including Canada.
Dr. Branchetti said a data monitoring safety board review, expected in early February 2022, is set to evaluate the safety and futility of the data collected thus far. The last board review was conducted in June 2021 on 97 patients, including those reaching one and two years follow up, and resulted in the trial continuation with no safety concerns.
The second Phase 3 study, CardiAMP CMI, began treating patients in October 2021, and it is expected to enroll a total of 343 patients. She said the trial has an adaptive design with preliminary efficacy analysis expected on the first 100 patients which “could potentially accelerate the development of this program.”