Palvella Therapeutics Inc Q2 2025 Earnings Call Transcript

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

Question: Ritu Baral - Cowen and Company LLC - Analyst : Good morning, guys. Thanks for taking the question. Wes, I wanted to dig in a little bit on the implications of the 25% over-enrollment in the Phase 3 SELVA study. Can you tell us what that does to your powering assumptions, and also, I guess, heterogeneity of the patient pool that you have ended up with and how that might impact any sort of variant on the endpoints that you see? If this has any impact on how you view the market, oftentimes over-enrollment can be a tell on patient numbers, etc. And then finally, what you plan to release with in urban (inaudible). Thanks.

Question: Ritu Baral - Cowen and Company LLC - Analyst : And the last thing, guys, just what you plan to release with the topline?

Question: Ritu Baral - Cowen and Company LLC - Analyst : But can you specify what secondary would be released at the same time at this point?

Question: Ritu Baral - Cowen and Company LLC - Analyst : Understood. Thanks for taking all the questions.

Question: Annabel Samimy - Stifel, Nicolaus & Company Inc - Analyst : Hi there. Thanks for taking my questions. Had a few. Just -- you mentioned your focus right now for the SELVA trial is just ensuring compliance. How are you ensuring compliance for those patients? And just want to understand, if there's something that's being a 24-week trial? Is that going to be more difficult for them, or is the efficacy large enough for it to be self-insuring, let's just say?

Question: Annabel Samimy - Stifel, Nicolaus & Company Inc - Analyst : Okay, got it. And I know a lot of people think about mLM being an indicator for cVM, but how do you think about it the other way around? You will come into the cVM data first. So is that going to be a reverse strong indicator, just further support that the Qtorin platform is really delivering drug deep into the dermis where it is? Like, I guess, should we see cVM proof-of-concept as a good indicator for how mLM or consistency of data in mLM. So just thinking about it the other way.

Question: Annabel Samimy - Stifel, Nicolaus & Company Inc - Analyst : Okay, got it. And one last question if you can indulge me. I know that you've done various population analyses for mLM. You're still talking about greater than 30,000, but I guess recently you've been talking maybe the range is higher, maybe the low end of the range is possibly 44,000. Can you talk about that and what are some of the other additional analyses that you're doing to truly identify what the size of this population is? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 14, 2025 / 12:30PM, PVLA.OQ - Q2 2025 Palvella Therapeutics Inc Earnings Call

Question: Annabel Samimy - Stifel, Nicolaus & Company Inc - Analyst : Great. Thank you.

Question: Danielle Brill - Truist - Analyst : Good morning. Thanks so much for the questions and congrats on all the progress. So I have a couple on TOIVA. Wes, you mentioned the trial's still recruiting. Can you just speak to the pace of enrollment there versus your internal expectations? And I guess specifically, what is the rate-limiting step to getting these patients enrolled? And then can you help contextualize for us how the cVM data might compare to the MLM data in Phase 2? Given the genetic heterogeneity here, what magnitude of efficacy should we be looking for? Thanks so much.

Question: Danielle Brill - Truist - Analyst : Perfect. Makes sense. Thanks again for the question.

Question: Ryan Deschner - Raymond James. - Analyst : Thanks for the question and good morning. Can you remind us what age range you're targeting for an mLM label at this point? And can you tell us anything about what age range patients already enrolled in the SELVA trial are skewing toward? And then I have a follow-up. Thanks.

Question: Ryan Deschner - Raymond James. - Analyst : Got it. And then also regarding the Phase 3 SELVA study in MLM, would the over-enrollment here more reflection of the high demand for good treatment for mLMs, or is it looking more like patient identification might be a little easier than expected based on actual prevalence? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 14, 2025 / 12:30PM, PVLA.OQ - Q2 2025 Palvella Therapeutics Inc Earnings Call

Question: Ryan Deschner - Raymond James. - Analyst : Got it. Thanks, Wes.

Question: Katherine Novak - Jones Trading - Analyst : Hi, morning. Thanks for taking my question. A couple on SELVA. So after last patient last visit, is there any follow-up or can you go straight into data cleaning and analysis? And then how -- approximately how long would that cleaning and analysis take, given that this is a single-arm study?

Question: Katherine Novak - Jones Trading - Analyst : Okay, great. And then for the cVM Phase 2, I know you said that there's no statistical hierarchy of endpoints. But which endpoint are you thinking about when you think about taking forward into the Phase 3? I know that FDA has in the past expressed a preference for static measures over change scales, and I'm wondering how you're thinking aboutthat when it comes to analyzing Phase 2. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 14, 2025 / 12:30PM, PVLA.OQ - Q2 2025 Palvella Therapeutics Inc Earnings Call

Question: Katherine Novak - Jones Trading - Analyst : Okay, got it. Thanks for the clarification and the color.

Question: Sam Slutsky - LifeSci Capital LLC - Analyst : Hey, good morning, everyone. Thanks for taking the questions. I guess just as a quick refresher, could you remind us on the potential commercial strategy in mLMs as it relates to initial target centers? What proportion of mLM patients are treated at those centers? Think about build-out, sales reps needed, etc.

Question: Sam Slutsky - LifeSci Capital LLC - Analyst : Awesome, thank you.