All right, good afternoon, everybody. My name is Alexa. I'm from the Cantor Biotech Equity Research Team, and we're honored to have Wes here today from Palvella Therapeutics. He will be presenting a slide deck. I wanted to just say thank you to Wes and the Palvella team for joining us at our Canter Healthcare Conference. I'm excited for everybody to learn more about the Palvella story. Great, good afternoon, everyone. My name is Wes Kaupinen. I'm the Founder and CEO of Palvella Therapeutics. First, I want to thank Alexa, Josh, Steve Aldridge, Jason Fenton, and the entire Cantor team for all their support of Palvella, including having us at this conference today. I'll be making some forward-looking statements. I'd like to refer you to our SEC documents for the risks associated with those statements. I'll begin today with the name Palvella, which in Finnish means to serve. The mission of our company is to serve those patients that have serious rare genetic skin diseases, and we're doing that through the development and planned standalone commercialization of targeted therapies for those patients. Our strategy as a company can be summed up in the word "first." We want to be first in diseases that currently have no FDA-approved therapies. We think that by delivering first-in-disease therapies, it can be transformational for patient populations who previously had nothing. We also believe that it's a sound strategy for our shareholder base. Our vision, as listed here, is to build an enduring biopharma company that truly leads in the area of serious rare genetic skin diseases. Over the past several years, we've now assembled the leadership team, late-stage pipeline, platform, and the capital base to execute on this vision. It's been estimated by Dr. Greg Licholai and others that there's approximately 597 rare skin diseases. Unfortunately, over 98% of those diseases do not have a single FDA-approved therapy. We are looking to change the paradigm here. The way we're going to do that is by developing drugs that are targeted therapies and first in those diseases. I'll just note here that this is a high unmet need corridor of the orphan universe. It's also a low competition corridor of the universe, and we believe those dynamics are ideally suited for Palvella to lead in this space. It's an exciting time at Palvella. A lot of new developments. Yesterday, we announced the hiring of David Osborne as our chief innovation officer. David was the co-founder and first employee at Arcutis Biotherapeutics, had an instrumental role in the discovery and development of ZORYVE. He also has an additional three dozen topical products that he's been involved with that have ultimately reached various approvals. We're excited to have David's talents on our team. David will be heavily focused on our QTORIN platform. That's our platform for reproducibly generating novel topical products. We'll be working closely with our Chief Scientific Officer, Jeff Martini, and the rest of our team to make sure we maximize the value of that platform. We also see in the second bullet a growing commercial opportunity for QTORIN rapamycin. Thanks to many researchers, it's been identified now that there's over 25 different diseases which are believed to be driven by the mTOR pathway. We therefore think QTORIN rapamycin, our lead product candidate, has clear and compelling pipeline and product potential. We will announce our third target indication for QTORIN rapamycin later this month. Over time, we think we can expand the addressable pool of patients by a factor of about 10x beyond our lead indication, microcystic lymphatic malformations. With microcystic lymphatic malformations, we are intensifying our U.S., commercial planning. That's accelerating under the leadership of Ashley Kline. We were fortunate to recruit Ashley earlier this year. Ashley is best known for leading the launch of OXERVATE, a topical therapy for neurotrophic keratitis. She is a proven executive in the commercial orphan space. Today, we'll share some new insights from some of Ashley's initial work on the physician and payer market research front. We have spent the last several years at Palvella setting up for the next seven months in the four high impact milestones you see listed here. We will announce our third indication for QTORIN rapamycin later this month. That will be in a disease that strategically aligns with the company's focus: serious rare, no FDA approved therapies, commercially attractive in nature. We will announce our number two, our second QTORIN program. That is a new API with QTORIN that will similarly be deployed to treat a serious rare disease with no FDA approved therapies, with clear biology, commercially attractive, and harnessing our capital efficient operating model. We'd like to get to phase II data in less than two and a half years and less than $10 million. The two panels on the right side of the slide, we expect to imminently announce full enrollment in our phase II TOIVA study, which is evaluating QTORIN rapamycin in cutaneous venous malformations, serious rare genetic disease, no FDA approved therapies. This is a phase II proof-of-concept study. We're enrolling approximately 15 patients there. We have FDA's fast track designation. We look forward to the top line readout in December of this year. On the far right of the slide, based on our highly statistically significant and clinically significant phase II results, last year we started enrolling a phase III pivotal study in microcystic lymphatic malformations, a serious rare chronically debilitating genetic disease with no FDA approved therapies. Target enrollment was 40. Our clinical operations team did an excellent job working with the clinical sites. We ended up enrolling 51 subjects. That study is also on track, similar to the cutaneous VM study. The timeline is there, that study will read out in Q1 of 2026. For both of those indications, if we're approved, we have the opportunity to be first line and standard of care for patients with cutaneous VMs and microcystic lymphatic malformations. I'll now describe our QTORIN platform. QTORIN is our platform for reproducibly generating novel topical product candidates, doing so in a capital efficient manner. Capital efficiency has been a pillar of the company since day one, since it was founded. With QTORIN, we're able to achieve high concentrations of the API in the vehicle gel. That is very important for a couple of reasons. Number one, we think that that leads to more predictability on rapid onset of therapeutic activity. We also think that it enables potential to see a large magnitude treatment effect by having more of the active at the site of disease. The site of the disease on the right side of the slide for many of these diseases is the dermis. That's the lower layer of the skin. We've shown with our first product candidate from QTORIN the ability to chaperone rapamycin into the dermis. We believe we'll be able to replicate that with additional molecules. From a safety and tolerability perspective, over the two years in 80 prototypes that we went through in developing QTORIN, we avoided the use of traditional penetration enhancers. We really believe we've optimized for favorable local tolerability for these patients. We've also shown across a number of clinical studies that we have low systemic absorption of rapamycin. That's the goal, which is to retain the drug in the skin while not having high levels of systemic absorption that might inflict unwanted toxicities on patients. With each QTORIN program, we're able to file new intellectual property and potentially generate long duration IP claims on each QTORIN product candidate. We have six issued patents on rapamycin. While rapamycin should have broad potential and does have very broad potential in skin diseases, the current options are inadequate. On the left side of the slide, rapamycin is a potent immunosuppressant. It has a number of systemic toxicities and probably most importantly, it does not distribute well to and within the skin. That is a suboptimal construct for treating skin diseases. On the right side of the slide, there have been significant barriers to a commercially viable topical formulation of rapamycin due to the poor solubility of the drug, its high molecular weight, which restricts skin penetration, and the fact that the drug is chemically unstable. QTORIN with rapamycin, we believe, has overcome those challenges. We believe this to be a breakthrough innovation. We state that because we have received FDA's breakthrough therapy designation in microcystic lymphatic malformations. On the left side of the slide, you can see some of our key innovations with QTORIN rapamycin. First and foremost, we have a combination of co-solvents that we discovered that enable us to get high API concentrations into the vehicle. We're able to solubilize the drug to a 3.9% concentration. We think that's a major differentiator for the drug product. We're able to get levels of rapamycin into the dermis, the site of disease that exceed the IC90 for mTOR inhibition. As mentioned earlier, always optimizing for patient tolerability and safety across several clinical studies, we've shown limited systemic absorption of rapamycin. We've designed this drug product to be administered once daily at home with self-administration. The commercial opportunity for QTORIN rapamycin, our management team is very focused. We want to get approval in microcystic lymphatic malformations first. That's our goal. We want to be on label in microcystic LMs on a standalone basis. We think that's a multi-billion dollar total addressable market with 30,000 patients that we've validated through claims data at orphan pricing. Should we be successful in microcystic LMs, our second indication to go on label would be cutaneous venous malformations, assuming clinical and regulatory success. We want to keep adding to the label beyond that. With the third indication that we'll soon announce, we think we'll add an additional 50,000 patients from the addressable patient population perspective. As recently elucidated by Dr. Tatiana Lapa in a 2025 publication, there's many additional indications that we can pursue. We see a clear and compelling opportunity for a pipeline and a product with QTORIN rapamycin. Microcystic lymphatic malformations, like all Palvella Therapeutics diseases, there are no FDA approved therapies for microcystic lymphatic malformations. The genetics have been well elucidated. It's a PI3K mutation. The mTOR pathway is hyperactivated. You can see the result of that on the far right of the slide, genetically malformed vessels protruding through the skin. One of the major clinical issues for patients is lymphorrhea. That's the persistent discharge of internal lymph onto the skin into the soft tissue that leads to serious infections and in some cases, hospitalizations. Historically, these patients have been treated with destructive approaches such as surgery and sclerotherapy, with some off-label use of oral or topical mTOR inhibitors, albeit with a number of limitations. Our solution, QTORIN rapamycin, is designed to be on target, selectively, potently inhibiting the causal mTOR pathway, and doing so at the site of disease in the tissue, which is the dermis. We were really pleased to partner with a number of global key opinion leaders in microcystic lymphatic malformations on phase II proof-of-concept study. This was a 12-patient study with a baseline controlled once daily administration. Patients were evaluated over a 12-week period. The results from the study indicated clinically and statistically significant results on pre-specified global and individual endpoints. We'll review some of those now. I'll begin on the left side of the slide, which is the CGIC, Clinician Global Impression of Change. This is a single item instrument where the physician evaluates the lesion in clinic and scores the improvement or worsening of that lesion at a certain time point. Here we show week 12 highlighted compared to that patient's baseline level of severity. As you can see here at week 12, our average effect size was 2.42. That's on a scale that goes from negative 3 to plus 3. 100% of the patients in phase II proof-of-concept study were either a plus 2 or a plus 3, much improved or very much improved. Corroborating those results were the Patient Global Impression of Change, which had a similar statistical significance at week four, week eight, and week 12. The average patient was much improved. Our team put together a dossier, submitted this to the FDA, breakthrough therapy designation. We're very pleased to have that breakthrough therapy designation grant. We wanted to show a couple of pictures here beyond the pre-specified endpoints that show some of the changes that we saw in this phase II proof-of-concept study. Here's one patient on the left side of the slide. You can see the volume of the lesion, the bleeding, and then those small cysts, which are sometimes referred to as vesicles. On the right side of the slide, you can see an improvement in the volume of that lesion, reduction in bleeding, and the vesicle count has also improved. Similar result here for this patient at week 12, where you can see some hyperpigmentation, very little in the way of active disease. This was a great basis to be able to go to the FDA and submit for breakthrough and ultimately proceed to phase III pivotal study. From a safety and tolerability perspective, we saw low levels of systemic absorption of rapamycin, less than 1 nanogram per mL, significantly below the 5 ng per mL, which is the lower boundary for triggering immunosuppression in these patients. We also saw the absence of systemic mTOR-related toxicities, which was encouraging. We think that this together, the efficacy of those results and the safety profile presented here, longer term, assuming phase III success, presented a very compelling risk-benefit rating. phase III pivotal study here is being done under the leadership of Dr. Joyce Teng. She's the Head of Pediatric Dermatology at Stanford, long-term collaborator to Palvella Therapeutics. Here we set out to enroll 40 patients. The design of this study, very similar to phase II, single arm, baseline controlled study. Thanks to more demand than we anticipated, as well as great execution by our clinical operations team, we ultimately were able to over-enroll the study and keep it on track. We enrolled 51 subjects. Data is on track for Q1 of 2026. I wanted to spend a minute on the phase III design relative to phase II. Phase III design mimics the phase II study. As you can see here, both are baseline controlled, both at PD dosing and rich for moderate to severe patient populations. We've made a couple of key enhancements to the primary endpoint, which mimics the clinician global impression of change. From an FDA perspective, we've been granted breakthrough, fast track, and orphan drug designation if we're successful in phase III. We would anticipate an expedited regulatory pathway based on those designations, as well as a planned 505(b)(2) submission. We're also grateful to the FDA for their financial contributions to this study. We were the recipient of an FDA orphan drug grant. The FDA's orphan division manages a small pool of capital that they grant non-dilutively to certain sponsors developing in rare diseases. Last year, there were 51 applications for that program. Seven awardees are phase III study based on the single arm, baseline control. It's the only phase III study that was supported. We've received the initial proceeds from that grant. We're very grateful for the collaborative effort. From a U.S., commercial planning perspective, thrilled to have Ashley on board full-time working with the team. She's a proven commercial veteran in the space. Her success with Oxervate, she was able to drive that drug from launch to more than $500 million in sales by year five of the launch, one of the more successful orphan drug launches of the past decade. You can see here what really equates to an executive summary from her time in the seat here over the last few months. We think we have quantified that this is a large orphan market through claims data and other EPI work. More than 30,000 patients estimated in the U.S., with more than 1,500 patients annually being added to that pool. We are positioned to be the first and only FDA-approved therapy. There is a strong intent to prescribe from our preliminary market research. We'll go through some of that data. We've also done more work around orphan pricing analogues and some payer testing. We do expect an orphan pricing corridor based on those results. Because of the emergence of vascular anomaly centers at pediatric hospitals over the last 20 years, this is a market for the reason. Concentrated prescriber base, about half the patients with microcystic lymphatic malformations are in approximately four other centers in the United States. I think those are favorable dynamics as we think about sizing of our commercialization. In terms of our market research, I'll start on the left side of the slide, our core intent to prescribe insights. We did market research with 52 treaters of microcystic lymphatic malformations. 98% of those physicians indicated when presented with the product profile of a 3.9% rapamycin gel. We included some of our phase II results. In that product profile, 98% would consider product X to be a first line therapy. We were similarly encouraged by their intent to prescribe this to 75% on average of their patients. We have some new additional insights on the right side of the slide. We did some testing around the pediatric population. 96% of the physicians that we surveyed saw advantages to targeted localized delivery compared to what's available today, oral mTOR and PI3K inhibitors. From a physician segmentation perspective, we did see consistency between those physicians who were at vascular anomaly centers, their intent to prescribe, and non-vascular anomaly centers. Finally, 17 out of the 52 physicians indicated they would prescribe this product to their full patient load at 100% of the patients. From a patient concentration perspective, we've invested in claims data. We think that that's the gold standard in terms of understanding EPI and working on targeting from a center perspective. Claims analysis supports three segments. The first segment that's going to have a disproportionate amount of resources from our commercial team will be those high volume centers. We estimate that the highest volume 400 centers in the U.S., comprise about 50% of the market. There are already established centers of excellence that treat microcystic lymphatic malformations. We intend to cover all three segments, both with a direct orphan sales force. We estimate somewhere between 20 and 40 reps. We will also use other methods such as inside sales. We're going to apply additional learnings from Ashley's experience with OXERVATE. We're carefully studying other orphan launches. There have been many successful orphan launches recently. We want to extract the best learnings from those launches and apply them to QTORIN rapamycin 3.9% anhydrous gel. This is also new data from payer research that we've done in conjunction with our partners at ClearView Healthcare Partners. Here we looked at, with 11 payers, the budget impact of launching QTORIN rapamycin 3.9% anhydrous gel. There were expected to be minimal budget impact from the launch of our drug to these payers. Not surprising in some ways, given the rarity of the disease. There was a favorable reaction to the target product profile we put forward, which was based on our phase II data from both an efficacy and a safety and tolerability perspective. We would not anticipate, based on this research, any step edit with patients having to be forced to step through off-label, unproven, and in some cases unsafe systemic or compounded surveillance. We've outlined here, in addition to some of the recent topical launches in rare diseases, some analogs that we think guide on a potential pricing range for QTORIN rapamycin. I had the experience at Insmed while I led the U.S, commercial team there to work on the preparation for launching Arikayce. I'm certainly familiar with that drug and where it priced at the launch of 2018. Ashley has led OXERVATE's launch. Quite successful. She led the pricing work there. Of course, the Peza, a drug that has been very successful for a rare disease population. What we'll do from a pricing perspective is we'll generate our phase III data. We'll go through incremental payer testing with that phase III data. Ultimately, we'll approximate the launch, announce a U.S., launch price. Next year is going to be a busy year for our Medical Affairs team. We expect to have a strong presence at several congresses, vascular malformations, dermatology conferences, as well as hematology oncology conferences. There we anticipate building on the already established KOL relationships we've been able to build over the last several years, as well as driving disease state awareness and conducting other market shaping activities. Moving to cutaneous venous malformations, like all Palvella Therapeutics diseases, no FDA approved therapies. This disease, also the genetics have been characterized, is driven by one of two mutations, PI2 or PIK3CA. mTOR is hyperactivated here, which is really driving the proliferation of these dysregulated and malformed veins impacting the skin. These patients have bleeding, thrombosis, ulceration. About 50%- 80% of venous malformation patients have some cutaneous involvement. Today, they're typically treated with laser, sclerotherapy, off-label pharmacotherapies. Those are inadequate. The field is really clamoring for an FDA approved targeted pharmacotherapy that inhibits the causal pathway in this disease. You can see here, we've sort of bifurcated internal venous malformations, which is not on our target on the left side of the schematic. On the right side is our target, which is cutaneous venous malformations. That's the patient population that we're studying in our phase II study, our ongoing phase II study. You can see how debilitating this disease can be for these patients. Bleeding, thrombosis, ulceration ultimately has a significant impact on quality of life. The current unmet need here is for targeted localized therapy for this disease. There's a large, growing evidence base that supports the use of rapamycin in venous malformations. Here we've summarized some of the off-label use of systemic rapamycin, which is typically used for internal venous malformations. On the far right of the slide, some of our European collaborators published and noted that rapamycin in Europe has emerged as the gold standard for treating venous malformations, although their call, as you can see in the quote, is for topical agents that can address the cutaneous venous malformations while abolishing the unwanted toxicities from the systemic treatments. Here we have an phase II proof-of-concept study. We will imminently announce full enrollment of this study. We're pleased to have Megatolison as our Principal Investigator. We've had three sites activated just in the last two months. No statistical hierarchy on endpoints. This is a rare disease that hasn't been studied by a company before. We have a number of clinician and patient-reported outcomes, severity scales, change scales, and we look forward to reporting top-line data in December of this year. We've had similarly encouraging market research. At 90% of physicians we surveyed noted that the product profile, that topical 3.9% rapamycin gel, certainly should be considered compared to systemic approaches. 86% when presented the product profile would consider this first line. We build on this. We've got to generate phase II data. If the phase II were successful, we do have fast track designation. We'd be at FDA advocating for breakthrough therapy designation, trying to swiftly move it into a phase III pivotal study. In terms of additional milestones, our R&D team is hard at work. As previously mentioned, we'll announce the next QTORIN rapamycin indication. The target for that is later this month. That'll be in a serious rare disease where there's no FDA approved therapies, commercially attractive. Very excited to make that announcement and also later this year to announce our next QTORIN platform. From a finance perspective, very grateful to our investors who stepped up and participated in an oversubscribed PIPE financing in December of 2024 that was led by BBF and Fraser, with participation from several other investors, including longtime supporters of Palvella, PetraCorp, and Ligand Pharmaceuticals. We have approximately two years of cash runway, $70 million in cash on the balance sheet as of June of this year. Our innovations are protected through a multi-layered exclusivity strategy with six granted U.S., patents on QTORIN rapamycin, several trade secrets which are not included in our patents, and anticipated regulatory exclusivities. I'll wrap up to say that all of us at Palvella are really energized about where we are as a company. It's been years in the making. We really are striving according to our mission to be first for these rare disease patients who have been neglected. We think it's going to be transformational to bring forward first approved therapies both for these patients. We think it's a sound strategy for our shareholders as well. We have a late-stage pipeline. We have a platform that's going to be guided by David Osborne, the preeminent drug developer in this space. If approved with QTORIN rapamycin, we anticipate having the first approved therapy being standard of care. Our phase III, we believe, is designed for success. If successful, we've set up for an expedited regulatory pathway. As we're shifting the organization to be more commercially minded, we see a multi-billion dollar total addressable market at microcystic lymphatic malformations with many follow-on opportunities to build on that market opportunity. Thanks to our team who's been hard at work in putting together this deck, driving the success of our clinical trials. Thanks again to Alexa, Josh, Jason, and Steve for having us today. Thank you very much.