Zentalis Pharmaceuticals, Inc. Common Stock Wells Fargo 21st Annual Healthcare Conference

Well, thanks so much. Thanks for having us.

For having us. We appreciate you giving us some time today.

Happy to do that. I won't be remiss in mentioning we're going to be making some forward-looking statements, and we appreciate those listening, taking a look at our SEC filings for the risks and uncertainty around those statements. I have fulfilled my legal obligation. So, on to your question. I have had the pleasure of working with an amazing team the past 12 months, and looking forward to the next 12 months, as we've accomplished a lot on our agenda with our very focused strategy to bring azenosertib to the market for patients in the platinum-resistant ovarian cancer space, in particular for our biomarker-selected population of high expressers of cyclin E1 protein. So in the last 12 months, we have begun and enrolled two parts of our DENALI registration-intended study.

This is the DENALI Part 2 trial, where we've enrolled Parts A and B, and we're currently enrolling cohort 2C in that trial. We also have gotten alignment with the agency, the FDA, around our ASPENOVA phase III. That is our randomized trial that will not only support accelerated approval but will eventually transition the accelerated approval to full approval, and also for global commercialization. So a lot going on. We've even started bringing azenosertib forward in the ovarian space with our MUIR trial Part 2 in combination with bevacizumab. That is in patients who have progressed while on a PARP inhibitor in the first-line maintenance setting. We are studying those patients in the second-line maintenance setting. So lots has happened. Maybe I forgot, most importantly, we have confirmed and selected our monotherapy dose of 400 milligrams, a single dose daily, five days on, two days off.

Yeah, thanks. Do you want to address, Ingmar?

Happy to, yeah. I would like to start by saying that the FDA lifted the hold, right, without any request for changes to the dose and the schedule. That is something that, of course, is important, and I have not seen in my career really that from a hold, without further requests, the hold was just lifted. Nonetheless, that is something that, of course, drove us to rethink management and study oversight, and that is something when we came in, one of the first things that we started to do, and we moved to really real-time study oversight. That means that we have a bunch of clinical scientists and medical monitors that are really focused on really starting their day by looking at the database, see if there is data missing, if there is any signals.

Something that is not left to a CRO, but it is really one of the core focuses of the company right now. If there is anything that alerts the team, then we will proactively reach out to the investigator. More importantly, because, of course, you want the investigator to be able to handle the drug, and learn to manage the drug, which certainly given the profile, which we think is very positive, is possible. There is an education piece as well. That is something that we have gone through and where we see this bear fruit by really, the things we preach are really adopted by the investigators and the site personnel, so that really is important. Lastly, we just clarified, mostly not on severe side effects, which are not so many with azenosertib anyway, but those who are, of course, impacting convenience and quality of life.

There we just strengthened the antiemetic schedule. Antidiarrheal medication. It just has more clarity and is more straightforward, and also leaves less room for interpretation, and that really resonated.