Veru Inc. 12th Annual Cantor Fitzgerald Global Healthcare Conference

Muscle, that will be great. We are highly focused on what a label would look like that could be testable in this patient population.

Yeah. The idea is you want incremental weight loss, and you get the incremental weight loss by holding onto muscle. Yes, muscle is a problem, and the reason it is a problem is because patients that are older have less muscle to begin with, and even though they lose the same proportion of muscle, they have less muscle starting out. We have, in our phase II-B QUALITY study, shown that 44% of patients on semaglutide alone at 16 weeks had a greater than 10% decline in stair climb power. The loss of muscle matters from a function standpoint. The market that we are going after is the 40 million patients over the age of 65, of which half can benefit from a weight loss drug.

The answer is, as I mentioned in my comments just before, the problem is that 90% of patients with a BMI greater than 35 will still have, technically, obesity at a year, and they have hit the PLATEAU where they cannot lose any more weight. We have to fix that problem, but at the same time, we have to make sure they do not lose muscle. Interestingly, some new studies are starting to show if you want the cardiovascular benefit from weight loss, you have to hold onto muscle.

Yeah, it is a great question. We have always been thinking about our program from a standpoint, what would an FDA label look like? Our discussions with the FDA is, it is one thing to say that you preserve muscle, it is another thing to get a label that says that. The FDA is not interested in making a cosmetic statement that you held onto lean. You have to show what does that mean to the patient. Our first clinical trial, the phase II-B QUALITY study, proved that patients have loss of lean, have a problem with a functional endpoint. FDA likes stair climb, they like functional endpoints. They are not so much interested in cosmetic or strength endpoints. We know that. The FDA wants you to pick a patient population that you can benefit.

Just to say, "I am going to take all patients and preserve muscle in all patients," that does not work. If you say something like, "I am going to take patients that have functional limitations, that are older, patients greater than 65 that have less muscle, they want to be on a GLP-1 to get the cardiovascular benefits of a GLP-1. If I treat them with a muscle preservation drug, can I preserve their function?" How do you measure that function? A lot of discussion with the FDA is think two things. Think of what you want your label to say that you are going to do to benefit the patient. Second, make sure your safety database also thinks about the fact that probably all patients are going to want to take a drug like this.

Right. Focus first on the patient population that is at risk.

The FDA doesn't tell you what they want.

Okay. They tell you what they don't want.

What do they- They want a functional endpoint.

Stair climb has been used in muscular dystrophy in the past. Stair climb has been used in frailty. The literature is filled with information showing the benefits of stair climb as a measurement of anabolic activity and measurement of how a patient ages. It's very sensitive in detecting changes in decline. The reason that's important is because the detriment in stair climb links and bridges to the frailty data that shows that if you have a problem with stair climb, then you're going to have a problem with balance, gait, you're going to have falls, you have fractures, your hospitalizations go up, mortality goes up. So essentially, what we're trying to say is that older patients want to get the cardiovascular benefit of a GLP-1. But if they're trading that off for hip fracture, that's not good. Can you get both? Again, the focus, focus is on a method that shows function and is sensitive to the patient population.