I remember that you (or maybe another poster?) wanted to see Cryoport adding a bunch of phase 1 trials. I would rather see more phase 2 and 3 trials that are closer to commercialization, and have larger patient populations at multiple locations, since they present a much higher revenue potential for Cryoport. I think the increase in the number trials is one reason for the revenue beat last quarter, but going forward, commercial revenues will far outpace this.
Generally, phase 1 trials are testing for safety, and (since they don’t want to kill a bunch of people) they are only tested on a very small number (handful) of patients. Although a majority (~65%) are successful and move on to phase 2, less than 10% make it to approval. One reason for the small number of phase 1 trials that Cryoport supports is that many are conducted at a single site that doesn’t require Cryoport’s services. I looked at this last year and discovered Cryoport was landing a majority of new phase 1 trials, but yes, Fisher Bio and World Courier are probably the biggest competition in this area. This clinical trial breakdown doesn’t really bother me. What is encouraging to me is that nearly 60% of phase 3 trials make it to approval, and Cryoport’s phase 3 trials continue to grow. If that percentage holds true, Cryoport is looking at close to 20 near-term approvals.
Historically, only about 30% of phase 2 trials make it to approval. but with the new RMAT guidelines, I think that percentage will go up significantly. Remember, the FDA approved Kymriah based on the results of the phase 2 ELIANA trial for B-cell ALL, and recently for DLBCL based on the phase 2 JULIET trial. And Yescarta was approved based on the phase 1/2 ZUMA-1 trials.
