Why Is BioCardia Stock Plunging Today?

BioCardia Inc BCDA shares are down after the company released interim efficacy results in the phase 3 pivotal CardiAMP cell therapy heart failure trial.

For the first tier, all-cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement at 12 months, there were 5.6% of CardiAMP treatment patients versus 5.3% for the control group (p = 0.42). 

24-month follow-up data showed a separation between groups, with 8.3% all-cause death, including cardiac death equivalents in the treatment group versus 13.2% in the control group (p = 0.94), corresponding to a 37% relative risk reduction for Tier 1 events compared to control patients on guideline-directed medical therapy (GDMT).

For the second-tier, non-fatal major adverse cardiac events (MACCE), excluding those deemed procedure-related occurring within the first seven days and defined as heart failure hospitalization, stroke, and myocardial infarction, 16.7% of the treatment group had MACCE compared to 15.8% of the control group (p=0.82). 

All available follow-up data for patients followed up to 24 months showed a 16.7% MACCE rate in the treatment group versus 23.6% in the control group (p=.76), corresponding to an 18% relative risk reduction for MACCE over GDMT.

For the third tier of change in the Six Minute Walk Test (6MWT) distance from baseline to 12 months, both CardiAMP treatment patients and control patients experienced a clinically meaningful improvement at 12 months, which was not statistically different. 

The treated group median 6MWT at 12M increased 36.1 with a standard deviation of ±70.8 meters, and the control group median 6MWT increased at 12M by 33.4 meters ± 74.8 meters (p =0.6). 

Results at 24 months showed the treatment group median improving 1.8 ± 76.1 meters and the control group median improving 17.4 ± 95.7 meters (p=0.33). 

The improvement in 6MWT at 12M for the control group was greater than was expected in this population.

Based on these measures at one-year follow-up, the 250-patient randomized controlled study is unlikely to meet its primary three-tiered Finkelstein-Schoenfeld (FS) efficacy endpoint.

Price Action: BCDA shares are down 23% at $0.60 during the premarket session on the last check Tuesday.