Good morning and welcome to the Precigen Papzimeos Approval Call. At this time, all lines are in a listen-only mode. Following the prepared remarks, there will be a question and answer session. Please note this event is being recorded. I would now like to turn the conference over to Steve Harasym, Head of Investor Relations. Please go ahead. Thank you for joining us to discuss the U.S. FDA approval of Papzimeos, the first and only FDA-approved therapy for the treatment of adults with recurrent respiratory papillomatosis, or RRP. With me are Helen Sabzevari, the President and CEO of Precigen, Phil Tennant, our Chief Commercial Officer, and Rutul Shah, our Chief Operations Officer. Before we get into this call, I would like to remind you that we will be making certain forward-looking statements. These statements are based on our current expectations. We encourage you to review the slide in this presentation and our most recent SEC filings, which include information that could cause actual results to differ from those in the forward-looking statements. After the prepared remarks, we'll open the call to Q&A. With that, I will now turn the call over to Helen. Helen? Thank you, Steve, and a warm welcome to all participating in calls today. Yesterday was a day of great significance for all those in the RRP community, the patients, their loved ones, treating physicians, and the RRP Foundation. For the first time since RRP was recognized as a distinct disease, there is now an FDA-approved therapy for adults. We are thrilled to announce that Papzimeos has been approved for the treatment of adults with RRP. It is the first and the only approved therapy for RRP and the first and the only approved therapy that treats the underlying cause of the disease. As you all recall, Precigen completed the submission of a rolling BLA in December 2024 under an accelerated approval pathway. I'm excited to announce that the FDA has granted Papzimeos a full approval. With this full approval, the confirmatory study is no longer required. The approval of Papzimeos also signifies the transformation of Precigen to a commercial stage company. Bringing this medicine to market with utmost efficiency and agility is an incredible accomplishment. I would like to send my profound gratitude to all those involved in this achievement. I will now take a few minutes to briefly give an overview of this rare disease. RRP is a rare, difficult-to-treat, and potentially life-threatening chronic disease of the respiratory tract caused by either the HPV6/11 infection. Until now, RRP was mainly managed by repeat surgical interventions. This disease affects both adults and children and can cause severe voice disturbances, compromised airways, fatal pulmonary lesions, and invasive cancers. Based on the extensive analysis of claims data, we anticipate a patient population of 27,000 adult patients in the U.S. alone. Given this patient data and the broad label, we believe we have a significant opportunity to maximize our reach and impact adults with RRP. Papzimeos has the potential to define a new treatment paradigm for this disease. Let's look at the prescribing information. We are excited to announce that we have received full approval for Papzimeos, which eliminates the need for the confirmatory trial. This is a testament to the clinical data, including a strong efficacy and durability and a favorable safety. In addition, we received a broad label, which makes all adult RRP patients eligible for Papzimeos and positions Papzimeos to become the standard of care treatment in this patient population. This broad label that covers all adult RRP patients will allow treating physicians to intervene at an earlier stage of the disease and potentially reduce the risk of irreversible damage that occurs from repeated surgery. Papzimeos is a non-replicating adenoviral vector-based immunotherapy. It is administered via subcutaneous injection of four doses over a 12-week interval. Importantly, the safety profile is extremely favorable. Papzimeos was well tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than grade 2. Here, I will take you through the pivotal data that led to the approval of Papzimeos. Papzimeos' mechanism of action targets the root cause of RRP. Upon subcutaneous administration, Papzimeos acts by generating an immune response directed against HPV6/11-infected papillomas in the patients with RRP. 51% of those treated met the primary endpoint of a complete response. This is defined as no need for surgical intervention for a minimum of 12 months following the completion of Papzimeos dosing. In addition, complete responses have been durable, and a vast majority of complete responses are ongoing. Specifically, 15 of 18 complete responders remain in an ongoing response at two years. We plan to present additional data at an upcoming medical conference showing ongoing durability of responses up to 36 months. Papzimeos induced HPV6/11 specific T cell responses in RRP study patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders. I would now like to turn the call over to Phil to walk us through our commercial strategy and launch plans. Phil? Thank you, Helen, and thank you to everyone listening in on this historic day. Let's turn to what makes Papzimeos a compelling opportunity for this rare disease population. This approval positions Papzimeos to become the new standard of care. Importantly, the product has a broad label covering adult patients with RRP, and it demonstrates durable complete responses. In fact, as mentioned, the vast majority of complete responders remain in complete response for two years, which speaks to the long-term efficacy and potential for sustained treatment impact. From a commercial standpoint, the value proposition for Papzimeos is extremely compelling. We are servicing a concentrated patient population. Integrated delivery networks, or IDNs, and community hospitals account for over 90% of patient potential. This allows us to focus our commercial efforts efficiently and support early adoption. In summary, Papzimeos combines its status as the first and only approved therapy for RRP with clinical durability and a targeted commercial footprint, making it a compelling breakthrough for RRP patients and the broader healthcare system. Let's talk about launch execution, where we stand today and why we are confident in our ability to scale quickly. We know that there is demand for a therapeutic treatment option that addresses the underlying cause of the disease, and we are ready to meet the demand with the launch of Papzimeos. We've built a robust commercial infrastructure to support Papzimeos. Our 18 dedicated sales territories cover over 90% of the ENT patient potential. This footprint ensures our ability to reach the highest volume of prescribers at launch. Our field teams, including Medical Science Liaisons, Payer Engagement Specialists, and Sales Leadership, have been in place since April and making substantial progress in building key relationships. We've completed targeting across IDNs, community hospitals, and other healthcare providers, covering over 90% of the account patient and procedural potential. Pre-approval information exchange, or PAI, presentations with population health decision-makers have also laid the groundwork for market entry. We've also built a strong base of national and regional thought leaders to champion early access. Our commercial distribution channels, patient health services, and support platform, p apzimeos support.com, are fully operational to support launch. In addition to the online portal, we have established a dedicated support line for providers and patients to be able to call. To put this in perspective, 93 IDNs and community hospitals account for 80% of our target potential. Our total IDN community hospital universe includes approximately 500 accounts. We're also supporting formulary and P&C processes for cross-payers and IDNs. As we look ahead, we've outlined a clear framework for tracking the commercial success of Papzimeos in several key areas, and some of those critical areas are shown on this slide. We have begun and will continue to monitor national and regional KOL advocacy and support for Papzimeos. We'll be tracking detailed prescription metrics at the individual and institutional levels to understand the breadth and depth of utilization. In addition, we'll be paying close attention to market access metrics to understand the proportion of lives who are increasingly covered with favorable access. Finally, we will utilize our hub to provide the data we need to ensure all eligible patients are securing the support they need to access the treatment. Together, these metrics form the backbone of our commercial dashboard and will guide investor expectations as we build towards sustained revenue growth. On the subject of patient support, we're not just launching a product; we are delivering a full-service experience designed to accelerate adoption and ensure continuity of care. From a pricing perspective, we are priced competitively, and the price point is representative of the innovation and value Papzimeos brings to the market as the first and only approved treatment. Our support program is built to remove barriers for both healthcare providers and patients. It includes treatment education, insurance navigation, and order coordination through specialty pharmacy services. These resources streamline the onboarding process and reduce administrative friction for prescribers. We've also prioritized financial assistance and coverage support. Patients receive help understanding their insurance benefits and accessing affordability programs, which is critical for ensuring adherence. For providers, we offer dedicated support through the treatment journey, from education to logistics, making Papzimeos easy to prescribe and manage. This infrastructure is not just about access; it's about scalability. By enabling smooth engagement across IDNs, community practices, and payers, we're positioning Papzimeos for sustained growth and long-term market leadership. With that, I will now turn back to the operator. Thank you. Ladies and gentlemen, we will now begin the question and answer session. To ask a question, you may press star followed by the number one on your telephone keypad. If you're using a speakerphone, please pick up your headset before pressing the keys. To withdraw your question, please press star followed by the number two. Our first question comes from the line of Jason Butler with Citizens. Please go ahead. Hi. Thanks for taking the questions and congrats on the approval. Two for me. First, very sorry if I missed this, but what is the list price of the drug? Secondly, the RRP Foundation has a database of a large number of RRP patients. I guess, to what extent have you been able to leverage this already, or can you leverage this in the future to help refine patient and physician targeting? Hi, Jason. Thank you for the questions. I think in regards to the pricing, the first question I'm going to ask Phil to answer, and I'll take the second question. Hey, Jason. Thank you for the question. As we all know, it's for subcutaneous injections over 12 weeks. As I mentioned, we've priced it appropriate to the degree of innovation that it's bringing to this market as a rare disease treatment and the first and only approved treatment. The wholesale acquisition cost, or WAC price, for each vial of Papzimeos is $115,000. We believe this will support broad utilization of Papzimeos in our RRP patients. I'd like to stress, of course, that we have a comprehensive patient support program in place, which does include financial assistance for those that require it, ultimately helping RRP patients access therapy. We have a clear goal, which is to ensure every eligible patient will have access to Papzimeos. In regards to the RRP Foundation and the question, as you know, we have been extremely active in working very, very closely with the RRP Foundation from the beginning of this journey. Especially in the past two years, as you have seen on RRP Day that we have co-sponsored with the patient advocacy group, and Kim has been a tremendous inspiration and help in advancing this treatment for the patients in an indication that there has not been any approved therapy for, let's think about this, 100 years. For the past 100 years, people have known about this disease. The therapy, believe it or not, from the 19th century, the 20th century, to the 21st century has been the same, repeated surgeries that cause the damage. We are working very closely with the patient advocacy group and, of course, in establishing not only making sure all patients have access, but also from the perspective of the databases that can be very, very useful across the United States to identify the patient and to ensure that all patients have access to this treatment. We look forward to the continuous work and the excellent work that the patient advocacy group has done in this manner. Great. Thank you very much. Just to clarify, on the price, it's four vials per course of treatment, correct? Correct. Thanks for taking the questions and congrats again. Thank you. Thanks, Jason. Your next question comes from the line of Jennifer Kim with Cantor. Please go ahead. Hi. Good morning. Thank you for taking my questions and congrats again on the approval. Maybe to start on the broad label, and this might be a question for Phil, what are the expectations in terms of market access based on your conversations with payers in terms of treatment to trial criteria vs treatment to label? My second question is, just looking at the label, are there any limitations around re-dosing? I know that was a consideration for the confirmatory trial, but that's not required any longer. Thanks. Thank you, Jennifer. Thanks for the question. In terms of discussions with payers, as you could imagine, we've had extensive discussions with them. There's a high degree of anticipation. Fundamentally, they understand the unmet need. They understand the inappropriateness of surgery as a long-term solution for these patients. They're impressed by the clinical efficacy and the value that this drug will bring as the first and only treatment. We expect, in line with our label, that every patient is in a position to benefit from Papzimeos, and we'll be working with payers to secure broad access accordingly. Yeah. Jennifer, in regards to the re-dosing, as we have been communicating, the FDA has been extremely interested in this aspect. Our pivotal study included, obviously, a single course of four subcutaneous injections of Papzimeos, which could make a lot of scientific sense here to re-dose the patients to further elevate the immune responses against papillomas, to potentially improve the responses in hospital or non-responders, and eventually to extend the duration in the complete responders. As published in Lancet Respiratory Medicine, 86% of our patients had a clinical benefit in reduction or elimination of their surgical burden in 12 months after treatment. Based on that, and based on the safety also and the efficacy that has been seen from our pivotal studies, re-dosing makes a lot of sense. At this point, it will be for physicians to evaluate patients and decide on re-dosing. All right. Thank you. Thank you. Your next question comes from the line of Swayampakula Ramakanth with H.C. Wainwright. Please go ahead. Thank you. Good morning, Helen and team. Congratulations. I know this is a big win for you both and also for the patients. A couple of quick questions. Phil, are these vials a single-use vial, or can it be a multiple use? In terms of the launch itself, is it going to be in some sort of waves in the sense initially you reach out to the IDNs and then to the community hospitals and so forth, or is it going to be a complete launch across the different segments of the patient population? Yeah. Thanks, RS. To your first question, yes, single-use vial. Regarding the launch, no, I wouldn't say it's going to be in waves. We've clearly identified over 90% of the patients and the procedural concentration in the IDNs and the community centers. Our initial footprint includes both. We do know that the patients are concentrated in those centers. They've been on a tremendous journey for many years and ultimately end up having surgeries at these hospitals. As I mentioned earlier, of the 500 or so IDNs and community practices that are in the total target list, there are just under 100 of those that represent the vast majority of the potential there. That's where we'll be focusing our initial work. Thank you. That's all I have for you guys. Thank you very much, RS. With that, I'd like to thank you for taking the time to join us today. We are profoundly grateful to the NIH clinicians, the FDA, and most importantly, the patients and families whose trust, commitment, and perseverance made this breakthrough possible. The FDA approval of Papzimeos marks a truly historic milestone for the RRP community, delivering the first and the only approved therapy for adults with this rare, debilitating, and potentially life-threatening disease. With an estimated 27,000 adult patients in the U.S., this approval represents a fundamentally new era of treatment. This is a proud day for Precigen, especially our team who have worked so hard to bring this to reality. We look forward to swiftly delivering Papzimeos to physicians and patients and to continuing our mission to advance meaningful innovations for those with high unmet needs. Thank you again for participating. Thank you for joining us. Ladies and gentlemen, this concludes today's conference call. Thank you all for joining. You may now disconnect.