Veru Inc Q3 2025 Earnings Call Transcript

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

Question: Anthea Li - Jefferies LLC - Analyst : This is Anthea on for Dennis. I have two questions, if I may. On the modified release formulation of enobosarm, could you talk a little bit about if this new formulation still allows for fixed dose combinations, particularly with oral GLP-1s potentially down the road? And then on partnering ex-US, any updates there? And have you presented potential partners or had conversations about the novel formulation given there is a stronger IP there?

Question: William Wood - B. Riley Securities Holdings Inc - Analyst : Congrats on the quarter, team. I have -- just thinking about the sort of the Phase 3 design. I know this will come up more at the end of Phase 2 meeting this quarter. But it looks like based on at least the proposed 68-week trial design, it's incorporating sort of 2 RCTs that are sort of combined together, incorporating a dropout portion and then what may be also described as an add-on portion will patients come on or off enobosarm, testing what happens after these sort of changes occur. So I mean, I guess, could you just discuss this plan, maybe where this sort of -- maybe where you sort of came up with this and what you've incorporated from any peers' learnings thus far and into these designs and endpoints and maybe what endpoints you'll be focused on, including cardiometabolic that may be incorporated in this test?

Question: William Wood - B. Riley Securities Holdings Inc - Analyst : Appreciate that extra color. And just one more, if I may. In terms of expectations on where we may expect the full data from both the induction and the maintenance trials, I'm assuming that's going to be upcoming at a conference later this year or maybe if you could sort of point us in the direction on where we might be expecting that and then what additional color we may gain at these -- at those presentations?

Question: Leland Gershell - Oppenheimer & Co Inc - Analyst : Mitch, congrats on the progress you've been making. I just have a couple of questions on the new formulation. Just as we await issuance of the patents from those applications, just wanted to know if you could share sort of the degree to which -- what your observations were novel and unanticipated based on the technology involved and I guess, speaking to the confidence that you'll get those patents allowed and also speaking to the defensibility of those patents against potential generic pilots down the road.

Question: Leland Gershell - Oppenheimer & Co Inc - Analyst : Got it. Okay. That's very helpful. And then just a question on the Phase 3. Presumably, you'll be building in open-label extension beyond the Phase 3b. Just wondering if there's any need, do you think from a regulatory standpoint for any additional safety exposure work or if that's pretty much buttoned up with the Phase 3 and the prior work you've done with enobosarm?

Question: Robert Sassoon - Water Tower Research - Analyst : I have a question -- a couple of questions. The 17% of the population in the 3 milligram enobosarm group that reported a clinically significant decline, physical function loss. Were there any sort of characteristics, obviously, outside of -- given that, that group was generally preserved lean mass. Is there anything -- any particular characteristics of that population, subpopulation that think you caused that statistic?

Question: Robert Sassoon - Water Tower Research - Analyst : And on your Extension study to the Phase 2, you have some pretty robust results when enobosarm became a monotherapy. It seems like that there is quite a large suite of populations. I think I read something like 11% of the adult population in the United States has non-obese sarcopenia. Is that a group of people that you would consider using enobosarm as a monotherapy at some point?

Question: Robert Sassoon - Water Tower Research - Analyst : One more question. How much -- when you go -- when you start to execute on Phase 3, how much capital do you think you need to -- do you estimate you need to raise?