Palvella Therapeutics Inc Q3 2025 Earnings Call Transcript

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

Question: Josh Schimmer - Cantor Fitzgerald - Analyst : Okay. Thanks for taking the questions. First on the TOIVA study, recognizing that you're not necessarily framing the key endpoints to focus on prospectively, how should we think about interpreting the data? And what should we be thinking in terms of perhaps a threshold effect that you'd want to advance further into clinical development? And then for the parakeratosis indications, maybe you can share a little bit about the other ones that you're considering exploring down the road, the parakeratosis of the belly and then linear parakeratosis, I'm sure what those lesions are like and how it compares to DSAP?

Question: Ritu Baral - TD Cowen - Analyst : Good morning, guys. Thanks for taking the question. Two for me. Wes, could you just address how your ongoing interactions with the FDA have been? Specifically, I think there's a lot of client questions on stability of the review team, especially given some overlaps of your review team across all of your programs because of domain expertise on the agency side? And then sort of the same question, but for the SELVA data, the Phase III SELVA data. Can you, I guess, the primary endpoint and maybe secondaries as well, but help us define what's good data versus what's home run data in the context of not really having any competition and any nuances that investors should keep in mind around the safety tolerability profile when evaluating sort of the totality of data?

Question: Ritu Baral - TD Cowen - Analyst : Got it. And if I could squeeze one more follow-up. The IgA scale, Wes, I think you mentioned in the -- I'm sorry, I think you mentioned in your plans for the angiokeratoma indications that there is the potential to use the SELVA endpoint. Does that refer to the IGA scale? And how much will the SELVA data inform the potential design of both the Angiokeratoma and the DSAP proof of concept studies?

Question: Danielle Brill - Truist Securities - Analyst : Hi, good morning. Thanks so much for the questions. First, as a follow-up on the CVM data and what to expect in terms of the endpoints that you'll disclose, can you walk us through a bit more details on what you're thinking? Like will you share pre and post treatment pictures? Do you plan to share details on the parameters that are changing such as lesion bulkiness, color or maybe pain? Any kind of additional color on what we should look for there will be helpful. And then I have a question on DSAP and the new QTORIN statin program. Can you just expand a little bit on the efficacy improvement that you're expecting here over the compounded statins? Based on a preliminary search, it looks like they're somewhat efficacious. Are there certain limitations that you believe you'll be able to overcome with QTORIN? Thank you.

Question: Ryan Deschner - Raymond James - Analyst : Hi, congrats on a busy quarter. Two questions for me. One, can you walk us through your thinking, sort of the rationale in the serial supplemental indication strategy and how that would work in practice vis-a-vis basket studies and other routes? And then now that your development pipeline has expanded meaningfully, how much overlap are you expecting in terms of prescriber base across MLM, CVM, ANGIO and DSAP? Thanks.

Question: Trevor Allred - Oppenheimer - Analyst : Hey, good morning. Thanks for taking my question. I had a question on DSEP. Can you provide any further detail on how the current topical treatment of 5FU proceeds? Just how painful or burdensome is the treatment course?

Question: Catherine Novack - Jones Research - Analyst : I think you've touched on this in the past, but we're still getting questions on regarding IP on QTORIN rapamycin, other QTORIN assets. What IP patent protection do you have on these assets? And how much protection comes from IP versus trade secrets, specialized processes, etcetera?

Question: Catherine Novack - Jones Research - Analyst : Understood. And then just a little bit more on TOIVA when it comes to how we should be thinking about weighting the specific outcomes. In the past, we've talked about FDA's preference when it comes to static versus dynamic scales. So is that something that we should also be waiting when it comes to when we see TOIVA's top line results?

Question: Dev Prasad - Lucid Capital Markets - Analyst : I have a question on commercialization. From a regulatory and commercialization perspective, what remains the major CMC or scale up milestone between now and the potential submission? And how far along are you in preparing for commercial manufacturing at the launch?