Palvella Therapeutics Inc To Discuss Topline Results from the Phase 2 TOIVA study Transcript

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

Question: Josh Schimmer - Cantor Fitzgerald LP - Analyst : Great, thanks very much for taking the question and congrats on the results. Maybe just to clarify, the estimated 75,000 patients with cVM in the US, what percent have superficial lesions that would be amenable to QTORIN Rapamycin and perhaps as part of that, maybe you can comment on the screen failure rate in the study for depth of lesion or other considerations. Thank you.

Question: Josh Schimmer - Cantor Fitzgerald LP - Analyst : Can I just clarify then that when you say cutaneous, you're referring to very superficial lesions and not ones that might be slightly deeper in the skin and, as such, less amenable to a topical approach?

Question: Josh Schimmer - Cantor Fitzgerald LP - Analyst : And that's when you say cutaneous, that's superficial cutaneous, yeah.

Question: Josh Schimmer - Cantor Fitzgerald LP - Analyst : Okay, thank you very much.

Question: Ritu Baral - Cowen and Company LLC - Analyst : Good morning guys. Congrats on this data set. A couple of quick questions here. Well, maybe not so quick, but I'll limit myself here. Place, sorry, natural history, I would say, how would you have expected based on natural history, any sort of placebo arm would have performed on the primary endpoint and amongst the numerous secondaries, are there any of these that are particularly I would say impervious to placebo effect?

Question: Ritu Baral - Cowen and Company LLC - Analyst : Got it. And then just going to slide 16, this was the time course of benefit on 2 point improvement. Wes, what does this tell you about what you're thinking about for the next study? I mean, it sounds like based on powering and sort of normal thresholds, you could do like a week 4, week 8 study on efficacy. Would you want to do something longer to show an even better benefit, do you need it for exposure, how should we be thinking about the next study and what you're going to propose to FDA? Thanks.

Question: Ritu Baral - Cowen and Company LLC - Analyst : Got it. Sorry, and I -- one quick question from a client just on the subscales of the cVM-IGA, I think you mentioned that height was a factor and color of affected veins. Are those the two main subcomponents of the cVM-IGA, and how does that overlap with the mLM-IGA, which is your, FDA green lighted primary up for TOIVA? 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 15, 2025 / 1:30PM, PVLA.OQ - Palvella Therapeutics Inc To Discuss Topline Results from the Phase 2 TOIVA study

Question: Ritu Baral - Cowen and Company LLC - Analyst : Got it. And I'm sorry, I misspoke. How does that assessment compare to the mLM-IGA for or Selva? Sorry, I mean.

Question: Ritu Baral - Cowen and Company LLC - Analyst : Great. Thank you.

Question: Sam Slutsky - LifeSci Capital LLC - Analyst : Hey, good morning. Thanks for taking the questions and great work on today's update. It's kind of two for me. Any details you can give on CVM average lesion size and the amount of drugs needed versus MLMs, anything related to compliance as well as patients, and then anything to note on discontinuations, and then have one follow-up.

Question: Ryan Deschner - Raymond James - Analyst : Thanks for the question and congratulations on the broadly successful readout. Two quick questions. Can you give us any additional detail on what the static severity scale metrics such as CGI-S and [PGIS] looked like at baseline, and I'm curious if there was a particular patient characteristic at baseline that was associated with stronger improvement or conversely associated with more modest improvement.

Question: Ryan Deschner - Raymond James - Analyst : Got it. Thank you very much. And then maybe just very quickly, was there anything notable or can you give us any additional color on the patient that was lost to follow-up? Thank you.

Question: Ryan Deschner - Raymond James - Analyst : Okay.

Question: Kaveri Pohlman - Clear Street - Analyst : Hey, good morning. Congratulations on the results and thanks for taking my questions. Maybe one for Dr. Kelly. Can you provide any additional insight on how well do the current trials reflect real world patients considering the inclusion, exclusion criteria, lesion count, and prior or subsequent therapies, and to what extent could additional clinical data, greater awareness, and the convenience of the topical option expand the addressable market, including patients who are perhaps initially managed with monitoring? And I have a follow-up.

Question: Kaveri Pohlman - Clear Street - Analyst : Got it. That's very helpful. And maybe, another question again, Dr. Kelly, how do you see this therapy fitting alongside current options like [sclerotherapy], [bleomycin] use? Also given comments previously made by the company that early intervention may alter disease course, if QTORIN Rapamycin is used first line. Do you anticipate any impact on the effectiveness of subsequent treatments like [bleomycin] that would influence how you sequence the [care]? Thank you.

Question: Geulah Livshits - Chardan Capital Markets LLC - Analyst : Good morning and congrats on the data from me as well and thanks for taking the questions. So maybe staying on the topic of early treatment of this trial, I believe, is in patients ages 6 years and older and the SELVA trial and you guys incorporated a cohort to enable expansion to younger patients. Is that something you envision doing in the CVM setting as well? And I guess for Dr. Kelly, would you feel comfortable treating very young patients based on the efficacy and safety that we're seeing here so far? 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 15, 2025 / 1:30PM, PVLA.OQ - Palvella Therapeutics Inc To Discuss Topline Results from the Phase 2 TOIVA study

Question: Albert Lowe - Craig-Hallum Holdings LLC - Analyst : Hi, thanks for taking my question. I was wondering, for the two patients that didn't improve by overall assessment of week 12, did any of them have any changes, improvements or worsens at any earlier time points, or was it consistently zero? And also, going back to the natural history that you referenced and the progression of disease, would you expect patients to worsen without therapy over this short period of time? Thanks.

Question: Albert Lowe - Craig-Hallum Holdings LLC - Analyst : Great, thanks. Maybe a quick follow-up. I was wondering if you saw any guess differences in time to response or any other differences by genetic mutation subtype? 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 15, 2025 / 1:30PM, PVLA.OQ - Palvella Therapeutics Inc To Discuss Topline Results from the Phase 2 TOIVA study