Veru Inc To Discuss Topline Results Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Gary Nachman - Raymond James & Associates, Inc - Analyst : Hi, good morning. And congrats on the readout. So Mitch, can you provide any color on the 2 doses, the 3-milligram and 6-milligram and how they trended in terms of lean mass, fat, mass and function with the stair climb? Which dose or doses would you pursue in the Phase III, are you contemplating just 1 dose with your proposed end of 470 patients? And then also on the total body weight loss, that was roughly the same in the two groups with the enobosarm, it was slightly less. Just how do you explain that? Was it because muscle weighs more than fat?

Question: Gary Nachman - Raymond James & Associates, Inc - Analyst : Okay, great. If I could just ask one quick follow up, so you expect the face to trial to be 52 weeks. How do you think that the drug will trend when you just go farther out from the 16 weeks on the key endpoint? So, were you seeing continued improvement as you got to the 16 weeks, we obviously don't have the benefit of seeing the charts and the trend over 16 weeks. But your confidence that you would see continued improvement when you go further out? Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JANUARY 27, 2025 / 1:00PM, VERU.OQ - Veru Inc To Discuss Topline Results

Question: Gary Nachman - Raymond James & Associates, Inc - Analyst : All right, great. Thanks for all that color. Appreciate it. Mitch.

Question: William Wood - B. Riley Securities - Analyst : Thank you. And congratulations, and I appreciate you taking our questions today. We know that the study remains blinded, but I was curious if there was any extra color you could provide on safety specifically GI tolerability, sense of concern with GLP-1s. And then also in terms of liver enzymes that may have been reported thus far whether they've been in line or if you have any granularity on, if they're in line for both enobosarm and placebo groups.

Question: William Wood - B. Riley Securities - Analyst : Okay. I appreciate that. That's very helpful. And then additionally, I know, for your Phase III trial, you selected stair climb power as measured by greater than 10% power from baseline, with the updated FDA guidance as you mentioned. But also just in terms of what we've seen from, I'll call it improvements in, 6-minute walk test specifically from just wegovy treated patients by themselves with nothing else. Could you maybe discuss what the FDA has said about stair climb power endpoint versus say a 6-minute walk test? And what that means in terms of functional benefits for a given patient?

Question: William Wood - B. Riley Securities - Analyst : Got it. Appreciate that, Mitch. And actually, just one quick, last one with the Phase III have a maintenance portion or a follow up after the 52 weeks and then I'll hop back into queue.

Question: William Wood - B. Riley Securities - Analyst : Got it. Thanks, and congratulations again, and thank you for taking my questions.

Question: Leland Gershell - Oppenheimer & Co. Inc. - Analyst : Hey morning Mitch. Thanks for the data release and the -- for taking our question. Just wondering, in terms of the safety data not being released yet, obviously a bit atypical from investors perspective, is that something that was required for you to maintain the blind for the second part? In terms of the protocol, was there any option for you to have just closed the safety data from the first portion?

Question: Leland Gershell - Oppenheimer & Co. Inc. - Analyst : You I know, that they are not teasing up for my follow up, which is you're seeing, preservation of lean mass with the 3. It doesn't seem like it's, much incremental with the 6, but you do see obviously much better of that mass loss with the 6. Would it be fair to say that? I think at 16 weeks. Right? Would it be fair to say that the sort of the -- I don't know, the view would be kind of the default view would be that if a 3-milligram go forward? 6-milligram less likely or unlikely?

Question: Leland Gershell - Oppenheimer & Co. Inc. - Analyst : Great. Thanks for taking the question. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JANUARY 27, 2025 / 1:00PM, VERU.OQ - Veru Inc To Discuss Topline Results