CG Oncology, Inc. Common stock 12th Annual Cantor Fitzgerald Global Healthcare Conference

Sure. Thanks, Josh. CG Oncology is developing cretostimogene, which is an oncolytic immunotherapy for the treatment of cancer. Our initial focus is in non-muscle invasive bladder cancer. The landscape is evolving rapidly, but really, I think we have built a body of evidence to suggest that creto can work across all of NMIBC, starting in high-risk BCG unresponsive disease, moving into BCG exposed, potentially BCG naive, as well as in intermediate-risk non-muscle invasive bladder cancer. Just today, happy to share that from the BCG exposed results earlier this year, we are actually planning our third phase III trial, which we can get into as well. This will be in the BCG exposed high-risk setting, comparing cretostimogene plus gemcitabine versus gemcitabine. I am pleased to share that we have had very positive FDA alignment on the trial concept.

The full details of the trial design will be revealed later on once we have our 12-month complete response rate in the creto plus gem data that is going to be available later this year.

It's a great question, and one that we asked the FDA directly. It turns out that for patients with BCG-exposed disease, technically, you should give them more BCG, and then they could potentially turn into BCG unresponsive disease. However, in an era of BCG shortage, what we're noticing in the community is many practices are actually just giving single-dose gem. It's based on that feedback that we've gathered from the real world and from sites that we work with. This turns out to be a pathway that is acceptable both from a regulatory perspective as well as from a clinical feasibility perspective. We may potentially also offer up the opportunity, if you go on single-dose gem, to access creto subsequently.

I wouldn't say single dose. I should say monotherapy gemcitabine.

I think when it comes to high-risk disease, we tend to go beyond a year. Which is something that we focus on given the higher risk and stage of that disease. Based on our Cohort CX data, this was combining creto plus gem, we tested it in 2 different schedules. Currently, we're leaning towards the sequential schedule. Simply, the data looks very comparable both in the high 80s, 90s. It really comes down to tolerability and convenience. The sequential therapy seems to be more tolerable compared to the concurrent administration schedule.

Exactly. Basically we tested creto, gem as the sequential regimen. That forms the basis of it. In the induction course, it's actually creto, gem, creto, gem. You basically take out one of the cretos and replace it with gem. On the maintenance, it simply would turn into creto, gem. Instead of 3 creto weekly administrations.