The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: William Wood - B. Riley Securities Holdings Inc - Analyst
: Congrats on a successful year. I'm just kind of curious, in your press release for PLATEAU, you noted that there's going to be an inclusion
of GLP-1 whereas at least in the past, you've spoken of using only tirzepatide, which is highlighted in your most recent deck. During PLATEAU,
there's the potential for 2.4 mg sema, 7.2 mg sema 25 mg oral sema and then oral and then obviously also tirzepatide to all be approved.
So I'm just curious, will any GLP-1 be allowed in your Phase IIb? Or will it be limited to just tirzepatide?
And curious how we should sort of view the potential to achieve this 5% weight loss bar when placed with various agents. Do you feel that,
that remains the same or it sort of lower or higher initial weight loss better to sort of set you up for success.
LSEG STREETEVENTS | www.lseg.com | Contact Us
consent of LSEG. 'LSEG' and the LSEG logo are registered trademarks of LSEG and its affiliated companies.
DECEMBER 17, 2025 / 1:00PM, VERU.OQ - Q4 2025 Veru Inc Earnings Call
Question: William Wood - B. Riley Securities Holdings Inc - Analyst
: Got it. That's helpful. And then also, when thinking about sort of the Phase I to Phase III transition. Do you have any insight on -- I know you
said that the FDA would allow for -- if you don't achieve that 5% bar, they would allow to incorporate or to look towards, say, a functional
improvement like strength, specifically stair climb. But how does that set up in Phase III?
Is that set up a dual endpoint in Phase III where you have to have where it's sort of an and or dual primary endpoint? Or would they allow
just a functional endpoint? How should we be thinking about that?
Question: William Wood - B. Riley Securities Holdings Inc - Analyst
: Yes. No, that's helpful. And I guess just actually one quick last one. I know you've mentioned in the past again that you were going to sort
of go for all comers but stratify. It looks like you're only targeting the greater than 65 patient population now in PLATEAU, and that's actually
sort of up from the greater than 60 years old in QUALITY.
So maybe just clarify what population you're targeting? And was that more FDA guidance or Medicare reimbursement dynamics or just sort
of the most in-need population kind of (technical difficulty).
Question: William Wood - B. Riley Securities Holdings Inc - Analyst
: Got it. Makes sense. Very helpful. I'll hop back in the queue.
Question: Rohan Mathur - Oppenheimer & Co Inc - Analyst
: This is Rohan on for Leland. Thanks for the update, just one question for me. As you think about the different outcomes from the PLATEAU
study and the obvious benefits of the enobosarm, do you expect there to be any flexibility around regulatory discussions that would follow
when it comes to showing a certain degree of weight loss from muscle function?
| 
