Veru Inc Q2 2025 Earnings Call Transcript

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

Question: Anthea Li - Jefferies - Analyst : Anthea on for Dennis. Could you talk a little bit more about how you're thinking about your cash balance and runway? Specifically, what options are you exploring to fund the Phase III? And is there a potential to partner out the program?

Question: Gary Nachman - Raymond James - Analyst : Thanks for all the updates. So Mitch, for the Phase IIb extension maintenance study, review what outcomes would be considered a success in terms of the magnitude of benefit on weight loss and muscle mass for enobosarm versus placebo after stopping the GLP-1. Does it need to be stat sig or just show a positive trend? And then if you could just say if the data is imminent or if it will be later in the quarter, if you could narrow that at all? And then I have a follow-up.

Question: Gary Nachman - Raymond James - Analyst : That's helpful. And then just in terms of the Phase III study, understanding that you still have to meet with FDA, what's your best guess on how big you think it will need to be? And are you leaning towards using the 3-milligram, 6-milligram or both doses and also doing it just for older patients? And then just quickly, any potential concerns with tariffs? So where is enobosarm sourced and manufactured, if you can comment on that thinking ahead, particularly for the modified formulation?

Question: William Wood - B. Riley - Analyst : Congratulations on a very nice quarter and very promising results, certainly looking ahead to those. Maybe just wanted to tease out a bit more on what you might have seen already on safety. Understanding it's blinded to-date, you did say that you haven't seen any significant differences compared to what you're expected or expecting based on the previous studies. So just to sort of help us out and set a bar, maybe you could provide some color on what your expectations are for the safety based on these prior studies and how we should be interpreting this in terms of just the general safety, but maybe specifically on these liver tests?

Question: William Wood - B. Riley - Analyst : Very helpful. I appreciate that very extra detail there, Mitch. So just one more actually from us. It looks from everything sort of that you presented so far, the FDA has sort of provided two paths towards -- two shots on goal or two paths towards regulatory improvement. You can sort of go after functional improvements or potentially go after metabolic improvements. It looks like you're sort of at least initially overwhelmingly targeting functional data, obviously, with your very nice positive stair climb also as your primary endpoint or in Phase III. I was curious, though, to how you're seeing sort of the other path if you feel that, that would be open to enobosarm. Also, I don't think we've seen too much data on that. And so how do you see these two alternate paths towards regulatory improvement? And will we -- or what should we be expecting as far as sort of the metabolic tests from the Phase IIb QUALITY coming up here shortly?

Question: William Wood - B. Riley - Analyst : I appreciate the color, but definitely on the lookout for the imminent data and congratulations again for a very nice quarter.

Question: Eduardo Martinez-Montes - H.C. Wainwright - Analyst : Eduardo on for Yi. Just a quick question again on the Phase III trial. You mentioned adding tirzepatide. And I'm curious what your thoughts are there. There's some anecdotal evidence that tirzepatide skews a little bit more towards fat loss instead of lean mass. I'm curious how you're planning around that in your trial design potentially. If you're losing more -- less lean mass, right, you might need a little bit more patients in that group to power a difference. I'm curious how you're thinking about that in the trial design?

Question: Leland Gershell - Oppenheimer - Analyst : Just wondering, Mitch, the industry has been investing a fair bit in the development of potential therapies for the side effect of the GLP-1s vis-a-vis the myostatin blockers and so forth. Wondering if the work you've done to look at the differences between ANOVO and perhaps those strategies, are there any concerns you may have that those may show any benefits that may supersede or be differentiated from ANOVO as we await the remaining data from the Phase II?