Good afternoon, everyone, and thank you for taking the time to join us today for our discussion related to the potential upcoming commercial launch of teplizumab, pursuing a new era for type 1 diabetes. Before we begin, I would like to remind you all that during today's event, we will be making forward-looking statements. I'd also like to remind you that our business has risks and uncertainties. To learn more about those risks and uncertainties, please review our most recent quarterly report filed with the SEC. Today's event is expected to run from now until about 2:30 PM. Our agenda for today will be led by our Chief Commercial Officer, Jason Hoitt, who will be providing opening remarks along with an overview of our key learnings as we've diligently prepared for the potential launch of teplizumab with the user fee goal date assigned by the FDA of August seventeenth, 2022. Following Jason, Dr. Kimber Simmons, Associate Professor of Pediatrics at the Barbara Davis Center for Diabetes of the University of Colorado School of Medicine, will then join us to provide an overview of her perspectives as one of the leaders of diabetes care in the United States. Following Dr. Simmons, our commercial leadership team members will also be joining us to provide overviews of our preparations and launch plans from each of their respective areas. Before turning the call over to Jason, I would like to note that we'll be hosting a Q&A session following the prepared portion of our event today. To submit a question, please use the Ask a Question tab featured on the top menu bar in the webcast portal, and I will moderate submitted questions to Dr. Simmons and our commercial leadership team during the Q&A session for their responses. You may begin submitting questions at any point during the event beginning now. With that, I will now turn things over to Jason to get us started. Thanks, Bob, and good afternoon, everyone. Thank you all for joining us today to discuss our commercialization plans and readiness for the potential launch of teplizumab later this year. In addition to sharing details of our launch plans and insights into this market, I'm excited to introduce you to our incredibly talented commercialization leadership team. Before getting into the meat of our commercial plans and readiness activities, I think it's worthwhile to spend a moment reflecting on Provention Bio's founding principles and what has led us to this moment. As many of you are no doubt aware, there are over 23 million patients living in the U.S. today affected by chronic autoimmune diseases, which are a leading cause of death and disability. Historically, the approach to autoimmune disease drug development has focused on the treatment of symptoms, generally in late stage disease when most of the systemic organ damage has already taken place. Provention Bio was founded on the principle that this is unacceptable, and we needed to do better. We believe that through the introduction of immunotherapy, we could intervene and ultimately prevent or delay severe autoimmune diseases ahead of irreversible tissue damage and organ failure, ultimately providing these patients with every opportunity to live their lives to the fullest. There's no better example of our conceptual platform of intercepting autoimmune diseases than teplizumab, and it has the potential to become the first ever immunomodulatory agent to address the root cause of type one diabetes, or T1D, which is the relentless attack on the insulin producing beta cells in the pancreas by activated T cells. Not only do we feel that teplizumab, if approved, will meet a significant unmet medical need in T1D. Teplizumab has the potential to catalyze change in the way that we diagnose and care for the disease. The T1D community has been waiting a long time for a therapeutic approach beyond insulin, and we can clearly see the resulting pent-up frustration and desire for new treatment modalities. Here you can see a newspaper headline from 1922 in the Toronto Daily Star, showcasing the first patients treated with insulin by Dr. Banting and characterizing this as a cure. We know that exogenous insulin is life-saving, but is by no means a cure for the disease. While there have been many advances in T1D technology, including continuous glucose monitors, insulin pumps, and hybrid closed loop systems that clearly have improved the quality of life for many patients, the community is yearning for, and frankly, deserving of more. Here you can see the excitement of the T1D community being expressed in reaction to the three-year teplizumab data when they were originally presented at ADA in 2020. In addition to the excitement we see from advocacy organizations like JDRF, we are also seeing medical societies like ADA rallying behind the potentially first ever immunomodulatory treatment for T1D. Here we see a quote submitted to the docket for the teplizumab Advisory Committee from Dr. Robert Gabbay, Chief Scientific Officer of ADA, encouraging FDA to rapidly approve this clinically meaningful treatment. Finally, another example from Jeff Hitchcock of Children with Diabetes, urging FDA to approve teplizumab and highlighting the burden type one families bear with insulin dependence. The theme, wanting to simply live without the burden of insulin dependence, is one we will come back to shortly as we discuss our market research. These are simply a selection of many examples of how we believe that teplizumab has the potential to catalyze change in the way T1D is diagnosed and treated, with earlier detection and treatment for stage two patients to delay the clinical onset of the disease. What does this opportunity look like? Among the 300,000 patients in the U.S. today with two or more autoantibodies, 200,000 of them are stage two, meaning that they have two autoantibodies and dysglycemia. Approximately 15% of patients diagnosed with T1D have a family member with the disease. By simply applying that math to the 200,000, we see a potential familial market opportunity of 30,000 individuals, and this will be the initial focus of our launch. Our rationale for this is threefold. First, by screening the relatives of the already diagnosed insulin-dependent population, we're enriching the pool of patients that are being screened, given the disproportionate risk of being the early stages of the disease for family members compared to the general population. Second, who better to advocate for their loved ones to get screened than someone who lives with the burden of insulin dependence every day? In roughly 50% of cases, they will have been initially diagnosed because they were in diabetic ketoacidosis. Finally, this is a group that is incredibly well connected to patient advocacy organizations. Whether it be through JDRF, Beyond Type 1, Children with Diabetes, Taking Control Of Your Diabetes, T1D Exchange, or other advocacy groups in the space, they are well connected with the latest developments in T1D. At the same time, in parallel to these familial efforts, we will be working with other key stakeholders such as advocacy groups, physician societies, public policymakers, KOLs, and others with a vested interest in T1D to make population-based screening a reality in the U.S. today as it is in countries like Finland. We believe the approval of an intervention will be a catalyzing force for these efforts. In addition to catalyzing change in the T1D ecosystem, we see the potential launch of the at-risk indication as the foundation of our franchise build around this asset. As you all know, the ongoing PROTECT study is fully enrolled, and we expect top-line data in the second half of next year. Beyond this indication, we see substantial potential opportunities to expand our label, focusing on younger age groups, repeat dosing and combination treatments, as well as potential new therapeutic indications such as celiac disease and autoimmune hepatitis, demonstrating the pipeline and a product potential of teplizumab. If approved for each indication, we anticipate a largely overlapping target list of prescribers for both the at-risk and newly diagnosed indications, providing obvious synergies as we think about the infrastructure required for our potential first and second indications. In addition, through treating at-risk patients, we believe physicians will naturally develop more experience and comfort with teplizumab dosing and their own patients' response to treatment. How are we going to accomplish all of this? It starts with having the right team in place, a team that has done this before with great success, and a team that has been a part of companies launching their first ever commercial products. That's exactly what we have here at Provention Bio. The leadership team that you'll meet today were specifically selected for their expertise in their respective areas, and I'm fortunate to have had the privilege of working with each of them at previous companies on other launches. Here you can see the companies and their respective backgrounds. Companies like Gilead, Sarepta, Vertex, and Corcept, having launched some of the most successful brands in the biopharmaceutical industry. Brands like EXONDYS 51 for Duchenne muscular dystrophy, another rare pediatric infused product, and Korlym for Cushing's syndrome. The same principle goes well beyond the leadership team, as you can see here, a profile of our medical team. This team was handpicked because of their specific expertise in T1D and endocrinology, having trained at some of the most prestigious programs in the United States and having launched multiple products in the space. Over the past two years, the team has dramatically advanced our understanding of this market and what it will take for us to successfully launch the at-risk indication. I'll get into some of those high-level insights in a minute, but I think it's important to put these in the context of the launch. In my mind, there are four strategic imperatives that will be critical to drive launch success as we build this nascent market. These four strategic areas are where you will hear the team focus today. First, awareness and screening for autoantibodies in at-risk individuals, and ultimately, routine screening during pediatric well visits at certain ages for all children in the United States. Second, HCP belief in teplizumab and desire to prescribe it for their patients, which we will discuss shortly. Third, minimize access and reimbursement barriers. You will hear details of our plans for market access, distribution, and patient services from Jessica Blumstein later this afternoon. Finally, our goal is to ensure that all customers have a positive and seamless experience with teplizumab, which will be discussed by each presenter today. As I mentioned earlier, core insights and understanding of our key stakeholder audiences are driving our launch plans. Over the past two years, we have conducted market research with more than 1,300 participants across multiple target audiences. As you can see, approximately two-thirds of the respondents are healthcare providers, including pediatric endocrinologists, adult endocrinologists, certified diabetes educators, mid-level providers, pediatricians, and more. Approximately 34% of respondents were patients or caregivers of patients with T1D. The insights gleaned from these pieces of market research are the foundation upon which our strategies and tactics are based. Let me get into some of the details. Our research efforts began two years ago with exploratory qualitative research. This piece of research conveyed an important insight that we've heard repeatedly, including in the quote I mentioned before from Jeff Hitchcock of Children with Diabetes, that T1D robs the entire family unit of peace of mind and normalcy. As Jeff said, it robs them of the time to simply live. As you can see here, irrespective of the audience, whether an endocrinologist, a certified diabetes educator, or a patient or caregiver, the same notion comes through consistently. Restoration of this peace of mind is what is currently lacking with the available treatment armamentarium. What do physicians say about teplizumab? In this next piece of blinded market research I'm going to show you, pediatric and adult endocrinologists were shown a target product profile for teplizumab and asked what their intent would be to prescribe this to their next 10 eligible patients. Respondents told us they intend to prescribe for an average of 93% of their eligible patients. Needless to say, we're quite happy with this intent to prescribe, but the natural next question is, what's the likelihood that a patient will take the treatment when prescribed by their physician? To answer this question and others, we fielded a quantitative piece of consumer market research with just over 200 participants. After reviewing a target product profile for teplizumab, 81% of patients and caregivers told us they would accept treatment if prescribed by their healthcare provider. In addition, 60% indicated that they wanted to know how teplizumab works, and nearly 40% of respondents indicated that they would call their HCP right away for more information about teplizumab. While this is incredibly exciting, we know that in order to know they are eligible for treatment before they're ever given a prescription, at-risk patients will need to be screened for two autoantibodies as a first step. We asked, how likely are you to be screened if your HCP recommends it? 89% of overall respondents and 96% of caregivers and patients with T1D would screen if it's recommended by their physician. In addition, we know that education is critical and why we launched two disease awareness campaigns in late 2020. 71% overall and 92% of caregivers and patients with T1D would screen their children just through learning more details about the autoantibody test itself. Rob and Jason will share a lot more information regarding our approach to screening and just how catalytic the first immunomodulatory treatment could potentially be in changing the treatment paradigm for T1D. With that, it's my great pleasure to introduce you to Dr. Kimber Simmons, who's Associate Professor of Pediatrics at the Barbara Davis Center for Diabetes and a well-regarded thought leader in the space. Today, we're fortunate to have Dr. Simmons here to discuss her perspectives on familial and population-based screening. Dr. Simmons. Good afternoon. I'm looking forward to talking to you about screening and early identification of type 1 diabetes. Here are my disclosures. The natural history of type 1 diabetes is well defined. We know that individuals who develop type 1 diabetes start off with a degree of genetic risk. There are over 50 genes that confer risk for type 1 diabetes. People who have a family history of type 1 diabetes or have a genetic marker can be at higher risk for development and have a 10-15 times increased chance compared to kids or adults who do not have these genetic markers. However, 85% of people with type 1 diabetes do not have a family history, and 90% of people with the highest risk gene do not develop type 1 diabetes. We know that there is more than just genetic risk. When a person has some genetic risk, a trigger which could be something in the environment, maybe an infection, causes the body to attack the cells in the pancreas that make insulin. This autoimmune condition results in the start of type 1 diabetes happening. At the beginning of type 1 diabetes, you can see these biomarkers of that autoimmune process in the blood. Type 1 diabetes associated antibodies or islet autoantibodies can be detected in stage 1, where the beta cells can still make enough insulin. However, the autoimmune process has started, and over time, the beta cells get destroyed enough that they can't make enough insulin. People enter stage 2, where if you look in their blood, you can see abnormalities in their glucose levels. However, these patients remain asymptomatic because their beta cells can still make enough insulin to let enough glucose in to keep them healthy. Eventually, the beta cells are so overworked and can't really make enough insulin to get glucose into the cells, and people develop stage 3 or clinical type 1 diabetes, where they have symptoms from high blood sugars. Unfortunately, a majority of people diagnosed in stage 3 of type 1 diabetes are very sick when they're diagnosed, and they have something called diabetic ketoacidosis or DKA. The symptoms of this are nausea, vomiting, heavy breathing, confusion, and it requires hospitalization. This happens because when a person can't get glucose for energy, they start breaking down fat. When they break down enough fat, the byproduct is making ketones, and their blood becomes very acidic, and it becomes very dangerous. Diabetic ketoacidosis is very common. If we look at our data in Colorado, we can see that over time, it continues to increase, unfortunately. Our most recent data shows that almost 60% of children diagnosed in Colorado present in diabetic ketoacidosis. The risks for presenting in DKA include being younger when diagnosed, being a minority race or ethnic group, having a lower income, or having a lack of private health insurance. DKA is also life-threatening. It's the leading cause of death in youth with type 1 diabetes, and the risk of symptomatic brain swelling is up to 1% and is likely much more common than this. It just goes unrecognized. DKA is costly. The average direct medical cost of a DKA episode in the United States is $18,000. Youth who have DKA use healthcare services more after they're diagnosed and have a higher cost for taking care of their diabetes after they're diagnosed. Importantly, DKA is a risk for poor health outcomes. The hemoglobin A1c is what we check to see how people are controlling their glycemic levels. In people who are diagnosed in DKA, depending whether it's moderate or severe, their hemoglobin A1c over time, so 10-15 years after diagnosis, remains higher than people who did not present in DKA by 0.9%-1.4%. Extrapolating this data, this suggests that people who present in DKA at diagnosis, who have prolonged hyperglycemia over years, have an increased risk for all of the complications that we work so hard to avoid. There's a lot of data recently also looking at the neurocognitive effects of DKA, and DKA is associated with lower IQ and worsened memory. This is a problem because type 1 diabetes is not going away. The incidence continues to rise. If you look at the graph on the right, you can see that in low prevalence countries such as the Czech Republic or in high prevalence countries such as Finland, the incidence, even though there are dips and peaks, over time, it gradually is increasing. The rate of increase is in all ethnic groups. What's interesting is the more recent data shows that the highest increase is in ethnic groups that previously had a very low prevalence. In the American Indian population, the rate of increase most currently is 6.1%. In the Hispanic population that we have a majority of in Colorado, the rate of increase is 2.4%. The good news is that we can identify and predict who will develop type 1 diabetes before they get sick. There are type 1 diabetes-associated antibodies that I mentioned earlier, islet autoantibodies, that have been able to be measured commercially since 2017. All of them, all four major ones. You can see that they're really just parts of the beta cell that make insulin. They're the little proteins that the immune system can respond to. If you look at the beta cell, you can see that there's GAD65, there's IA-2, there's zinc transporter 8, and then there's insulin itself. Those four major islet autoantibodies or type 1 diabetes-associated antibodies are what predicts the development of clinical type 1 diabetes. This graph on the right is very important because the staging of diabetes and the risk of diabetes really followed this paper that showed that in Germany, Colorado and Finland, who have longitudinal cohort studies that have followed kids from birth, once children who are either at genetically high risk or have a family member develop multiple islet autoantibodies, their risk for type 1 diabetes development is 70% in 10 years and approaches 100% over a lifetime. Based on the data we have seen from of the pathogenesis of type 1 diabetes, we expect this to be the same, whether it is somebody who has a family history or does not have a family history of type 1 diabetes. Importantly, type 1 diabetes fulfills criteria for screening, with one exception. It's an important health problem because type 1 diabetes is increasing. We know that type 1 diabetes is predictable with the measurement of islet autoantibodies. We have a test or examination, and we have that recognizable early symptomatic stage. DKA is common and life-threatening. The one thing that's been missing is an accepted treatment for patients with recognized disease. If a disease-modifying treatment is approved, then the World Health Organization criteria for screening will finally be fulfilled. American Diabetes Association has standards of care with recommendations that they publish every year. The recommendations have increased support for type 1 diabetes screening over time. In 2015, screening recommendations were introduced and said to inform relatives of patients with type 1 diabetes and to be screened in the setting of a clinical research study. In the most recent guidelines, the ADA recommended screening for presymptomatic type 1 diabetes should be done in the setting of a research study or considered an option outside of research for people who have a higher risk, such as first-degree family members with type 1 diabetes. In the community, my colleagues and I have discussed often what the future might look like. Once a treatment that can be given in early stages is approved, we think that it's likely that screening recommendations will be expanded in some way. This will likely go outside of just research and recommend that things are done clinically. In Colorado, we've been successful in screening individuals at high risk for type 1 diabetes for 30 years, and so I wanted to just share a little bit about that. The DAISY study screened 30,000 newborns in Denver. They took cord blood and looked for high-risk HLA, which is the gene that confers the highest risk for type 1 diabetes, so high-risk HLA genes. 2,542 of those individuals were identified and followed over time. TEDDY is a study that was built following DAISY and has locations over the United States and in Europe, and has screened 424,000 youth who had high-risk HLA and followed 8,766 of these high-risk youth. Type 1 Diabetes TrialNet is different because it's not a longitudinal study like DAISY, where DAISY followed high genetic risk or family members and TEDDY followed high genetic risk. Type 1 diabetes screens first and second-degree family members, but it's done at any time up to age 45. In Colorado, we've screened over 18,000 relatives who have a family member with type 1 diabetes and followed around 800 high-risk youth. These studies are really important. We do know, again, that 85% of people with type 1 diabetes have no family history, and so there really is a need to screen the general population, youth and adults, for type 1 diabetes. The research-based screening programs that are available are ASK, CASCADE, and PLEDGE. Although TrialNet screens family members, they also can confirm antibody status in the general population. There is now a consumer laboratory, Enable Biosciences, that individuals can request to be tested and receive a kit at their home. There are many clinical laboratories that physicians and healthcare providers are used to ordering clinical labs at that also offer islet autoantibody testing. Because ASK is in Colorado, I'm going to share a little bit about this program and the screening efforts. The next two slides show data from a newsletter that was published in November. You can see that in Colorado we have screened nearly 30,000 children for islet autoantibodies. Of those screened, 948 of those youth, because this program screens kids ages 1 through 17, were positive. Of those positive, 693 completed a confirmation test, which is important in clinical research. You can see at the time of this publication that 102 individuals were in stage one type 1 diabetes, so had islet autoantibodies with normal glucose levels. 55 were in stage two, so had islet autoimmunity, and some evidence of glucose intolerance. 49 had been diagnosed with clinical type 1 diabetes by the criteria that the American Diabetes Association uses, with only three of those presenting in DKA. One participant before we even were able to tell them the results. If you look at the 28,549 screened, and you look, there were two who had type 1 diabetes before confirmation, which is one of the DKA episodes. 928 were positive, so that's about 3%. You have to break that down into multiple antibodies, where we really know the risk prediction really well and single antibodies. If you look at the top purple box, you can see that 133 individuals or 0.47% of those who were screened were positive for multiple islet autoantibodies. This is a little bit higher than other general population screening studies, such as the one in Bavaria, Germany, where the rate is more like 0.3%. This translates to in Colorado right now, our data shows that one in 212 children have a high risk for type 1 diabetes development. Importantly, if you look at the dark purple do-boxes all the way on the right, you can see that the majority of people progressing to type 1 diabetes had multiple islet autoantibodies, as expected, and only two of those individuals presented in DKA, which is a clinical type 1 diabetes risk of only 5%. An 11 times lower risk of developing DKA is screened and followed compared to our clinical outcomes. This reduction in DKA in Colorado justifies the cost of a screening program, as there was a cost-benefit analysis that showed if DKA could be reduced by 20%, it would be beneficial. Support exists for individuals who screen positive. The ADA recommended that individuals who test positive should be counseled about the risk of developing diabetes symptoms, and DKA prevention. We have a program at the Barbara Davis Center that provides education, support, and can help patients, families, and healthcare providers navigate confirmation of test results, follow-up and access to early treatments. We collaborate with all of the groups like TrialNet, who have multiple centers and affiliated centers throughout the United States. Many children in our clinic would benefit if there was an early intervention available. To show currently what we kind of have in our clinic, we have 145 kids who we're following who are in stage 1 type 1 diabetes. 70 kids who we're following who are in stage 2 type 1 diabetes. We have 300 kids who have progressed through stage 1 to 2 to 3 or from stage 2 to 3 that would have benefited if an early intervention was available before they developed clinical diabetes. In the TN-10 study, teplizumab delayed symptomatic type 1 diabetes. When we're talking about possible early interventions, this is the one right now that looks like it will potentially be the first one if approved. The graph on the right shows that in individuals who received teplizumab, the delay in onset was by two years. There's a lot of question, is two years meaningful? Well, two years means 219,000 less decisions that someone has to make about diabetes, about 3,000 less injections, 4,500 less finger pokes, or 75 less CGM insertions, and also a reduced chance of the high blood sugars and low blood sugars that people deal with on a daily basis. As a person living with type 1 diabetes, as a provider who takes care of many children and adults with type 1 diabetes, and as someone who has lots of colleagues and friends in the type 1 diabetes community, we know that if there is an intervention that can give some people even one day without diabetes, it's very significant. The potential need for a treatment is outlined here. If you look in our clinic, we have about 400 new onsets a year. If you think about an average family in Colorado having at least two children, that means there's at least 800 first-degree high-risk siblings a year. If you look at the 5%-7% risk and use 5%, that gives us about 40 siblings with early type 1 diabetes each year. When you look at our state, we have 1.6 million youth less than 18 in Colorado, 8,000 youth with early type 1 diabetes. That means we've detected some of those kids, but 98% of the kids with early type 1 diabetes in Colorado remain undetected. If you look nationally, there's 84 million people less than 18 in the United States. Whether you use the 0.3% or the 0.47%, there's somewhere around or over 252,000 youth with early type 1 diabetes. This is just looking at youth, but this also doesn't acknowledge that about half of the people diagnosed with type 1 diabetes are diagnosed in adulthood. The conversation will change if there is a treatment for early type 1 diabetes that is approved. Right now, when somebody comes into clinic and they're diagnosed, the family says, "Is there anything I could have done to prevent this from happening?" Right now, we say, "No, there's nothing you could have done. You did a great job recognizing the symptoms and getting your child help, and we're gonna do everything we can to make sure they stay healthy." In the future, if something's approved, it will change to no, but if your child has any brothers or sisters, we could get them screened, and then there may be something that could work to help delay the onset of type 1 diabetes. Hopefully, eventually, we're able to say yes. If a treatment's approved and we know that it works, then hopefully we'll be at a point where general population screening will be more prevalent and part of well child care, and we can say yes, because if you do what's recommended by your physician, then we should be able to catch this early. If approved, teplizumab will change the management of type 1 diabetes. These are some of the big diabetes milestones that I feel have really impacted the care and lives of people with type 1 diabetes, mostly, you know, insulin being discovered and then all of the things where we can see how people are doing with their control and we can help them control their diabetes better, especially insulin, are important. With the approval of the first type 1 diabetes modifying therapy, this will be another really huge milestone when it happens and will be something that everyone really pays attention to and will change the course of how diabetes is managed in the future. In summary, screening for pre-symptomatic type 1 diabetes is widely available through research, consumer, and commercial-based laboratories. Screening programs that include follow-up reduce the incidence of life-threatening DKA and improve long-term outcomes. Screening allows individuals access to approved early treatment options. Once a treatment is approved and World Health Organization guidelines are met in full, healthcare providers and the scientific community are likely to recommend screening for type 1 diabetes, and families will also be more interested. With that, I'd like to introduce you to Rob Adamoski, the Senior Vice President for Medical Affairs. My name is Rob Adamoski, and I'm Senior Vice President of Medical Affairs. Thank you for the opportunity to present the Medical Affairs teplizumab launch plan and to highlight our T1D and screening education efforts. I first want to start by providing an overview of the existing medical affairs team. The leadership team has been in place for nearly two years, and over that time, we have developed our launch plan and executed against that plan. Through our collective efforts, we have made meaningful progress in increasing the understanding of the prognostic value of screening in T1D autoantibody testing. The team will expand further in July with six planned additional field medical scientist hires. This team was purpose-built, with nearly all members of the medical affairs team having a connection to T1D. Nine members of the team either have T1D themselves or have a first-degree relative living with the disease. Five individuals have either conducted basic science or clinical research, and nine of us have cared for individuals with T1D. The team is composed of endocrinologists, pediatricians, immunologists, nurse practitioners, physician assistants, and pharmacists. We have over 225 years of experience living with or caring for individuals with T1D. The goal was to develop a team with a 360-degree view of the disease and one driven by passion and dedication. The team has been incredibly productive over the past year. We've identified and engaged leading experts, and since October 2021, we've had over 1,200 engagements with these top experts. In addition, we have had numerous payer presentations, sponsored local and regional advocacy meetings. Our primary focus during this period has been on disease education, supporting efforts to increase T1D screening, identifying and profiling the leading centers. I will address this in greater detail on the next slide. Identifying these centers is based on three criteria. First, there's an existing T1D expert and someone who would advocate for the treatment of early-stage T1D. Second, they need to have experience with immunotherapy. Finally, they need infusion capabilities and support systems in place. We've been working through relationship building and educational support, including engaging in scientific exchange and answering unsolicited medical information requests with the leading experts in the US, some of which are illustrated at the bottom of the slide. Now we'll go into greater detail regarding our screening focus efforts. The key theme of this section is the appropriate collaboration with key stakeholders to amplify the educational programming and content available on the importance of proactive screening. Our short-term goal is to increase screening in high-risk individuals. This includes those with family history of T1D or other autoimmune diseases. In addition to the efforts of our field-based medical scientists, we're working with patient advocacy groups, publishing manuscripts in peer-reviewed journals, and supporting medical education, targeting all the key stakeholders involved in screening. Based on insights from our engagement, we believe the potential approval of teplizumab will be a significant catalyst for increasing screening. In the long term, our goal is population screening. There's already been considerable work done by academic centers, GatorApp, and the Helmsley Charitable Trust to map out a pathway for population screening and make autoantibody testing more affordable and accessible. We will continue to find compliant ways to support work with these stakeholders, which we believe will help accelerate this evolution in screening practices. One of the critical components of our plan is broad-scale educational programming targeting key stakeholders involved in screening. This plan leverages numerous channels to reach a wide range of healthcare providers effectively and has bespoke content for each target audience. We have appropriately partnered with all the major diabetes-focused medical associations and have supported educational programming at the major conferences. Through these efforts, we have reached 5,000 healthcare providers over the past year. In addition, we have supported two CME programs that targeted endocrinologists, pediatricians, family medicine, diabetes educators, and other key stakeholders involved in screening. These two programs had over 13,000 learners. Based on these programs' high level of engagement, we will further expand our educational efforts in the second half of 2022 and beyond. Now I want to discuss how we're going to work with advocacy groups and other key stakeholders in more detail. We're working with the leadership of all the key T1D advocacy groups and engaging through donations and grants supporting independent education on T1D and screening. The advocacy groups are also working together to amplify their impact. For example, awareness of the JDRF T1Detect screening program has been amplified by their alliance partner, BT1, and several other advocacy groups to maximize the impact and utilization of this innovative program. Now I want to discuss the T1Detect program in a bit more detail. Provention Bio, along with other diabetes-focused organizations, are sponsoring this program. This initiative has three distinct components. The first is a T1D education and screening awareness campaign targeting both community education and healthcare providers. The second component is a low-cost T1D autoantibody testing through Enable Biosciences, JDRF's partner in this initiative. The third and final component is monitoring and support. After an individual gets the results, they are provided with important information about T1D, and if appropriate, assistance linking them to care or to research studies for further evaluation. I briefly want to share an example of a T1D screening education we supported with other advocacy groups. This example, a video created by TCOYD on the importance of screening, was released during the National Diabetes Awareness Month last year and had over 10,000 views in a few short weeks. This is just one example of the high level of interest and engagement around the education on screening and reducing the risk of diabetic ketoacidosis and other complications of T1D. As Dr. Simmons discussed in her presentation, there are numerous screening programs in the U.S. focused on familial and population T1D screening. We believe the data from these trials will help provide further evidence of the value of screening that will help shape the further expansion of T1D screening. The momentum towards population screening has stemmed other T1D screening studies, including the most recent one started in Israel, which plans to screen up to 50,000 individuals with the same autoantibody assay used in the JDRF T1Detect program, and a population screening study in Australia that began in 2020. In summary, we've made considerable progress over the past two years with our own T1D and screening education efforts and supporting independent education programs from advocacy groups and other parties. We believe the approval of teplizumab will be another catalyst to drive increased screening and detection of early stage T1D. I'll now turn it over to Jason Levine, Vice President of Marketing and Commercial Operations. Good afternoon, everyone. My name is Jason Levine. I am Vice President of Marketing and Commercial Operations. It's my distinct pleasure to spend the next few minutes discussing our team's preparations for launch. We've taken advantage of the past two years to focus on educating the market on autoantibody screening, while in the background, gaining seminal insights into the market to prepare for the potential launch of teplizumab, which, if approved, will be the first ever disease-modifying therapeutic to treat appropriate stage two T1D patients. We believe that the potential approval of teplizumab can be the much-needed catalyst to change the entirety of the T1D market. While today, the reasons to screen for autoantibodies are less compelling, tomorrow will hopefully bring excitement, which will allow us to get to a new normal, where the default is to screen all relatives of those who have been affected by T1D. Whereas there had been low understanding of screening options, misperceptions around cost and access, there may soon be a breakthrough that changes the screening paradigm. With it, we believe objections to screening will be overcome and the reasons to screen become abundant and evident. We believe misperceptions will be debunked, advocacy and professional societies alike will line up to help the community fully understand screening and treatment and provide much-needed guidance to help people make informed decisions. Currently, we have two T1D screening education campaigns in market. Our healthcare provider, HCP website, ConnectedByT1D.com, provides those who care for T1D families with important information on the need for screening family members of T1D patients, different opportunities for screening, reasons to screen, and materials to help HCPs monitor and stage those who are screened. The concept has high stopping power and has been designed to help us overcome the first barrier to screening by reinforcing the increased risk of T1D in families with a relative who has been diagnosed. This creative campaign has been pulled through in HCP educational materials, including this disease education piece, which was created based on the feedback from our in-field pilot team. Chris Marley, our Vice President of Sales, will describe the team in greater detail later in today's presentation. We have learned that HCPs need essential information on the logistics of screening and importantly, how to stage and monitor patients, whether they test positive or negative for autoantibodies. Our consumer campaign, Type1Tested.com, includes an educational website targeting T1D families to discuss the increased risk, up to 15 times greater risk, of developing T1D. Get TypeOneTested, an omni-channel consumer educational campaign, is focused on driving the at-risk community to screen for type 1 diabetes early. The award-winning campaign features attention-grabbing imagery to draw our audience in and encourage them to get to know their risk for developing T1D, learn as much as they can to avoid serious complications, and make a plan with their healthcare provider based on their test results. We have provided our pilot sales team with a suite of educational tools for HCP offices, local advocacy groups, health fairs, and other events. These tools are meant to extend the online presence of the educational content described and provide printed resources for families to help encourage a better-informed discussion about T1D risk and screening. This includes a screening referral form that the endocrinologist can fill out to facilitate a smooth screening process and minimize potential obstacles for families. We continue to learn more about the performance of our omni-channel T1D and screening marketing as we have launched not only a customer relationship marketing tool or CRM, but we are also on Facebook, Instagram, Reddit, and Twitter. We have also piloted online radio. From launch October 2020 through Q1 2022, TypeOneTested website had more than 1 million total sessions and nearly 1.5 million page views. During the same period, paid social community engagement included nearly 15 million impressions. Through work with our advertising and media partners, we have continually optimized our media plans and channels. These targeting optimizations have brought the cost per session down 74% since Q1 2021 without sacrificing traffic quality, as evidenced by the consistent bounce rate. The success of our social media campaigns can be measured not only by metrics, but also by the wave of organic media that we've seen in the marketplace. The T1D community are hungry for new information about screening, and this is an example of our sponsored content on the left with Tanner Patrick, a social influencer who shares his T1D journey and urges others to screen to avoid dangerous outcomes like DKA. On the right is an example of a YouTube video featuring Ginger Vieira, a T1D mother of two who went to T1Detect, JDRF's screening and monitoring education and awareness program that provides access to order at home kits to screen for autoantibodies. This engaging video features Ginger walking through the testing process of her two young daughters and urging others to do the same. Let's take a look at a small portion of the video. We have also seen other companies, such as Labcorp, increase their education to customers. This includes education to overcome one of the misperceptions of autoantibody testing, that it is costly and not reimbursed. This statement is taken directly from Labcorp's website. Patient screening is straightforward, requiring a simple blood draw, and results are typically delivered within 8-15 days. Based on Labcorp data, 98% of patients paid less than $25 out of pocket for the diabetes autoimmune profile, and 65% of patients had no out of pocket costs. Along with our myriad non-personal activities, we have had our pilot commercial field team calling on pediatric and adult endocrinology practices, infusion centers, and local advocacy organizations for profiling meetings as well as T1D screening education. These discussions have proven successful in driving and changing conversations about screening. Among others, the pilot team has enabled us to develop strong understanding of the potential teplizumab treatment landscape to enhance our strategic approach at launch, gain real-world understanding of T1D patient journey, locally mapping the ecosystem of HCPs, advocacy, and non-prescribing influencers. Most importantly, we have been able to build key stakeholder relationships and identify centers of excellence and infusion centers that will have capabilities to treat appropriate patients at launch in order to accelerate our path to success. As you have heard, there's a tremendous buzz in the T1D community for a potential launch of teplizumab. It is likely better to hear the words of those who we have met through market research and advisory boards to help put things in perspective. Game changer. Life changing. Any extra time you can give is a gift. Even pushing it off a week would be amazing, let alone three years. This excitement continues to motivate us to ensure we support the community by preparing for a well-informed and successfully executed launch. Preparations have been going on in earnest for the possible launch of teplizumab after the FDA action date of August seventeenth. We aim to deliver a launch that establishes teplizumab as the new treatment paradigm that yields better outcomes for stage 2 patients and their families, change the way HCP and consumers think about autoantibody screening and working with the T1D community, educate on screening options and availability, which we believe has the potential to create unprecedented demand for screening, eventually followed by general population screening. Our belief is that screening behavior will change immediately if teplizumab is approved. As you can see from the market research above, a perfect storm is upon us. 92% of pediatric endocrinologists surveyed expect to increase screening for family members. 70% of those who currently identify as non-screeners stated they will start screening family members after seeing the teplizumab target product profile, or TPP. In addition, and importantly, nearly 90% of patients and caregivers would likely screen should their HCP recommend it. We are confident that there are opportunities available to address objections to currently not recommending screening for T1D family members with a possible teplizumab approval. Our launch strategies and subsequent tactics will continue to focus on these, and we will work tirelessly to increase screening rates to support patients who may benefit from an intervention. We also presented the target product profile to both HCPs and consumers and asked follow-up questions. In these market research surveys, HCPs intended to overwhelmingly recommend teplizumab to their eligible patients. 93% of endocrinologists say that they intend to treat or would offer teplizumab to their next 10 stage 2 patients. In addition, 81% of patients report that they would take teplizumab based on their HCPs recommendation. Our launch objectives include ensuring stakeholders have a strong belief in the unprecedented efficacy and promise for T1D delay, leading physicians to prescribe teplizumab for all eligible individuals. Address significant access or reimbursement barriers for teplizumab, and a positive and seamless end-to-end experience with teplizumab for all stakeholders. As you can see, we have well-informed strategies that will support the objectives and have enabled us to create a robust tactical plan to support a launch of what may be the first ever T1D disease-modifying treatment. Our launch critical target segments include first and second-degree relatives of current T1D patients and core targets of pediatric and adult endocrinologists who currently manage T1D patients. As we evolve and the launch matures, we will increase our commercial focus to the broader general population, along with primary care physicians and pediatricians. We will also be prepared to manage the number one barrier to treatment unearthed during market research, 14 days of infusion. You will hear more from Jessica Blumstein on the thorough preparations to ensure multiple models of care and sites of infusion, along with robust and compliant patient services aiming to create a seamless experience for patients and providers alike. We hope that you can appreciate the enormous amount of work that has gone into our launch readiness, along with all the successes we have had to date on our screening education programs. The T1D community has been waiting for decades for an intervention, and the T1D treatment landscape is ready for a paradigm shift. If approved, we believe that teplizumab will be that catalyst. I will now hand the presentation over to Chris Marley, our Vice President of Sales, who will walk us through the build of our sales organization. Good afternoon. I'm Chris Marley, Vice President of Sales, and it is my pleasure to share with you how we plan to engage critical members of the T1D treating community through personal promotion and support after approval. We believe the healthcare provider facing teams of Provention Bio will be a critical element in the success of our launch by educating and supporting clinicians throughout the treatment journey. Let me describe the makeup of this T1D treating community and the roles that they play with patients and caregivers. Pediatric and adult endocrinologists treat the vast majority of T1D patients. Within endocrinology practices, there are also nurse practitioners and physician assistants who care for T1D patients. These endocrinology specialists account for approximately 80% of our target list for the sales force. Beyond these prescribers, there are nurses, certified diabetes educators, dietitians, and more, who play a critical role in educating and supporting T1D patients and caregivers in the management of their disease. These endocrinology practices will be the focus of our sales team's efforts. We will also support the infusion centers where teplizumab treatment will be provided. In addition, our analysis of T1D treatment data and profiling efforts over the last year has identified an additional approximately 1,600 clinicians who care for large numbers of T1D patients but are not affiliated with an endocrinology practice, including pediatricians and primary care physicians. We will engage this group as well. Efforts began with an in-depth analysis of the T1D treating community through market research, which Jason Hoitt discussed previously, and analysis of the available T1D claims data. Utilizing the claims data, we were able to identify the roughly 400,000 healthcare providers who treat T1D in the U.S. However, the market is incredibly concentrated. We prioritize the healthcare professionals based on T1D treated patients and can cover about 50% of the total T1D market by focusing on just the top 8,300 healthcare professionals. All of these healthcare professionals have 5 or more treated T1D patients. As we dive a bit deeper, we deprioritize some non-endocrinology healthcare professionals to ensure full coverage of pediatric endocrinologists. A strategic focus for launch, helping us realize greater than 95% coverage of pediatric T1D patients. We then considered multiple scenarios that could affect our choices of field force sizing, including a range of forecast scenarios, potential impact to access to healthcare professionals due to COVID, and finally, what responsibilities would be assigned to each of our customer-facing roles. We settled on four customer-facing teams. Therapeutic specialists responsible for educating on autoantibody screening and teplizumab adoption. Field medical scientists within the medical team to engage key opinion leaders, healthcare professionals and payers on the clinical information and respond to unsolicited requests for data and infusion information support. A field reimbursement case management role within our access team, who will assist customer offices with procurement and reimbursement while identifying solutions to overcome patient access issues. Finally, a team of clinical educators who will educate and train staff at infusion centers on product administration. This effort led to the design of a customer-facing team that will cover greater than 95% of all T1D patients in our geographical footprint. The sales team will consist of 60 therapeutic specialists divided into eight regions, led by eight regional sales directors reporting into me. We will be focused on the T1D treating community and partnering with local and regional advocacy groups. We have already have a team of 12 deeply experienced sales professionals who have been engaging clinicians and advocacy leaders on profiling as well as disease and screening education efforts for the past year. I will discuss this effort in more detail in a few moments. The field medical team providing clinical support to our sales team will consist of 14 medical scientists split into two regions, led by two directors, reporting to one national director, Dr. Andrew Drechsler, who is a trained pediatric endocrinologist. We have a few more field medical scientists roles to fill, but to date have attracted a tremendous team of clinicians with vast T1D experience for this crucial role. Our Head of Medical Affairs, Rob Adamoski, outlined this team's wealth of T1D experience previously in the presentation. The field reimbursement case managers will be a team of four to start, with the ability to add to the group based on demand. This team will report to our Head of Patient Services, April Scott, who recently joined our team and has led patient services for several companies. Our Head of Access and Distribution, Jessica Blumstein, will provide further details on this crucial team later in the presentation. We expect the need for education and training on teplizumab administration with infusion centers will be high in the first stages of launch. However, we expect that need to lessen as teplizumab is routinely adopted and experience treating patient grows. Therefore, we plan to contract with a third party to provide a team to meet this need. Over the last year, we have had an opportunity to pressure test our thinking of how we would build this nascent market while beginning to build awareness of Provention Bio and autoantibody screening in our market. We developed and launched a customer-facing pilot team consisting of 12 sales team members launched in Q2 of 2021. We were able to attract a first-rate team that has over 240 years of biotech experience, many of which are in rare and endocrinology products. They have 75 product launches, including 32 in rare disease, and won 32 top sales achievement awards between them. They have greatly surpassed our expectations and substantially improved our preparation for launch as they have engaged over 1,500 targets with more than 3,000 personal interactions. Focused on profiling as well as disease and screening education with a very high penetration to the top levels of pediatric and adult endocrinologists. We have also completed 60 educational programs on screening with about 400 attendees. There has been a tremendous positive response to our team's engagement of healthcare professionals, Provention Bio's efforts, and the future of T1D care. These engagements have provided many insights into this market and strongly support our learnings from the market research covered earlier. Let's start with current provider capabilities and practices. The pediatric endocrinologists are the best prepared as a group. T1D is a focus in their practice. They are most knowledgeable about screening, have the resources to educate patients and families about the need to screen. They have infusion capabilities locally, and most importantly, a strong desire to delay the onset of T1D in children. We believe they will likely be the early adopters of teplizumab. While adult endocrinologists spend less time on T1 and they are screening less today, we have seen a strong response to our messaging about screening and believe many adult endos have a strong desire to offer treatment options to their stage two patients. The team has been able to identify approximately 120 potential teplizumab centers of excellence that have been evaluated for their potential to become early or later adopters based on motivation and experience, formulary processes, ability to implement or increase screening, infusion capabilities, and more. These include both large academic centers and local private practices who have met these criteria. Several centers have prior experience with teplizumab through the TN-10 study, and we have seen others working to implement broader screening programs. One key learning has been that the motivation within a practice, either the entire group or one healthcare professional to screen potential patients is key. Through our profiling efforts, we have found many motivated HCPs that are thinking about their organizational capabilities for screening and the future of T1D care options. The team has also gained significant knowledge of local treatment practices, understanding of how critical certified diabetes educators are to patient support and education, local infusion center capabilities for weekend hours and treatment of pediatric patients, referral patterns to endocrinologists from other specialties are all areas where our learnings have substantially improved. Finally, we have developed strong relationships with local T1D advocacy group leadership who are highly motivated and influential. We have been able to explore compliant opportunities to support their efforts, which will be critical to increasing awareness among patients and families. With these in-market learnings supporting our understanding of customer needs from our previous market research, we believe we are well prepared with our go-to-market strategy. Our efforts to build out the remaining sales team are well underway. Particularly encouraging is the number of outstanding candidates who have proactively reached out to us because of their personal connection to T1D and desire to be part of Provention Bio. We are looking to find salespeople who have experience in the startup company environment, have a strong track record in infused products and rare disease and/or endocrinology product launches. We plan to make offers that are contingent upon approval of teplizumab later this summer and have the team deployed by the beginning of Q4. We could not be more excited about the customer-facing team we have built to date and the tremendous candidates we have begun to engage to fill out this team. While much work remains, with the insights we have uncovered, plans we have in place, and the outstanding talent we have begun to attract to our organization, we are very confident in our abilities to meet the needs of patients and providers. Let me now turn it over to Jessica Blumstein, our Vice President of Access and Distribution, to tell you more about the work we have done with payers, distribution, and patient services to ensure access and support for as many patients as possible. Thanks, Chris. I'm Jessica Blumstein, Vice President of Market Access and Distribution. As Chris mentioned, I'd like to provide an update to the progress made by my team on market access, patient services, and distribution planning. First, I'll give an overview of our payer and pricing work, then share some details on how we plan to support the patient journey through our patient services program, COMPASS, and then close it out with how our planned limited distribution model will be set up to support a variety of infusion scenarios. When I started at Provention Bio a little over two years ago, I had a very limited understanding of type 1 diabetes myself and wondered what payers' awareness would be, as well as if they would perceive a therapy that delays onset of clinical stage type 1 diabetes by what we then knew to be a median of two years to be meaningful and something they would cover. Since joining, we have done a payer advisory board, pricing market research, a couple of focus groups, and our field market access team has met with over 75 key accounts covering approximately 270 million lives. What I can say from an overall takeaway message is, teplizumab is generally perceived to be a game-changing drug, and there has been great interest and enthusiasm from the payer community. That being said, this is the creation of a new marketing category, so educating payers on T1D as an autoimmune disease is important, as is the fact that patients can be identified prior to symptoms and clinical disease. With that foundation, the clinical data around the ability to delay onset of stage three clinical disease has been well received. In individual meetings, we have heard payers speak to teplizumab as true innovation when there has been none for T1D before. In addition to educating payers on T1D and the stages of the disease, autoantibody testing, and teplizumab clinical data, this year, prior to an approval, we will also focus on educating around how the company addressed PK comparability through a proposed modified dosing regimen in the BLA resubmission, expectations around patients in their population, and operational elements regarding patient services and distribution. In addition, we are developing the plans and frameworks for use with payers in a post-approval world, including the payer value story, and thus far the value messages we have tested in market research have resonated quite strongly. Lastly, our payer mix is estimated to be 60% commercial, 35% Medicaid, and 5% other. We do not anticipate contracting for access for a first-in-class product without any competition beyond any government-mandated agreements. In pricing research, typically, payers are blinded to us, and that anonymity seems to commonly lead to especially critical and negative feedback on potential coverage and pricing. The feedback we obtained in this research, however, was so positive that in my experience, it is exceedingly rare to receive. Payers, KOLs, and HCPs all perceive a high unmet need in type 1 diabetes, especially for stage 2 patients. When a target product profile for teplizumab was introduced and the participants were asked to rank teplizumab's perceived clinical benefit of meeting that unmet need on a scale of one to five, with one being no benefit and five being a major benefit, KOLs gave teplizumab a 4.5, which is impressive on its own. Payers, even more astoundingly in my mind, gave teplizumab a 4.2. For payers in blinded market research to rank a product above a four is rarely seen and reinforces just how important treatment with teplizumab could be perceived. For context, while we are obviously not a gene therapy or seeking approval as a cure today, ratings as strong as those are usually reserved for such products. When asked for pricing benchmarks, those a payer would on their own think of when they think of a price point comparator for teplizumab, they really could not come up with any. The good news was insulin was not in their minds as a comparator. It doesn't mean payers don't wanna know cost offsets regarding insulin, but they don't view it as an appropriate comparator. When the research team prompted payers to react to price points of a mix of biologic and specialty drugs, wide-ranging in price to get payers' reactions to these price points as comparators, we saw strong price potential for teplizumab, where the product was perceived to be high in value. Of note, what we heard from payers in this research was significantly beyond the MS or other analog numbers you may have previously heard referenced. Beyond that, where the rubber hits the road for payers really is at each of those different price points, how would payers manage drug utilization? What we learned there is that payers would mostly just manage drug to label or trial inclusion/exclusion criteria. Only at the highest price points tested did we begin to see managing by medical exception, which was seen as the greatest restriction. Ultimately, payers demonstrated they saw the benefit of the product and hope to not highly manage it. Of course, once we have a final label and a final price, we will see how that could change, but all of the work we have done in the past couple of years gives us great confidence. While doing everything we compliantly can to optimize payer coverage for teplizumab after approval, we also wanna optimize how we can compliantly support patients, caregivers, and physicians through their journey with teplizumab. In order to do so, we wanted to map out what the patient journey looks like from the beginning, where they are introduced to autoantibody testing to be identified as a potential patient throughout their journey to be treated with teplizumab and after. We mapped this journey out as a cross-functional team, and then from there, identified pain points throughout the process. These were really any pain points we could identify, not with a lens of only what patient services could address. Pain points range from education around autoantibody testing or understanding your test results, to being able to understand if your insurance provides drug coverage, or how do you figure out where you can get treated? The next step in the process was to determine which of the pain points we, as Provention, thought we might be able to develop solutions around. A good number of moments we could impact were ones that a patient services program could really help with, like appropriately assisting in the navigation of coverage for teplizumab if approved, and any prior authorization requirements. Support around how to plan for when and where to start your infusions, what to expect when starting a 14-day course of therapy, how to transition from one site of care to another. Training infusion staff that want to know how to infuse teplizumab and of course, also compliant patient assistance where patients are eligible. Before we designed a program that is meant to assist patients, caregivers, and healthcare providers, we knew we needed to get input and feedback from all of these important stakeholders. We held co-creation sessions with both adult and pediatric endocrinologists, nurse practitioners, office staff, and then in a separate session with both people living with T1D, as well as caregivers of people with T1D. The sessions were amazingly beneficial. While the journey work was validated and the moments that matter really resonated, the specific feedback and suggestions we got really helped us design a program that should meet the needs for this population, not just any cookie-cutter patient services program. At that point, we took all the work completed, the outputs of the co-creation sessions, and were able to lay out the critical elements of what our patient services team would be, who they would be, and what they would do. We created Compass, our patient services program. It is going to be a highly skilled, dedicated team of COMPASS navigators who will be Provention Bio employees that can help assist or navigate patients, caregivers, and healthcare providers appropriately through the treatment journey. Their goal will be to compliantly streamline the process, reducing barriers to access for patients and helping prescribers and infusion staff understand the process, how we can help, and training and education on the 14-day infusion. The navigator team will also be responsible for supporting field reimbursement, supporting on reimbursement questions and issues as they come up for physicians or infusion centers. Within patient services, there will also be an arm focused on infusion training for those centers and staff that may need it. This clinical educator team will be through an external partner with great expertise in infusion training and education. By using an external team who are highly trained and dedicated to our program, we can address the needs as they arise around training, but flex up or down the external support we need based on what the market dictates. Moving on to our distribution model. We know a 14 consecutive day infusion will be a challenge for some patients and their families, so we wanted to build the infrastructure to ease some of those challenges or barriers. We wanted to support multiple sites of care through our model as long as no setting is precluded by the label. One of the most critical ways then we can support the treatment journey is to create options and flexibility for treatment in a variety of sites of care. We believe we have designed our limited distribution model in such a way that it meets our patients and providers' needs, as well as be flexible enough to adapt as we go if necessary. We anticipate most of the initial patient starts will have all 14 consecutive days done in a hospital outpatient setting or in an infusion center as a new immunotherapy. Drug for this setting will be available for sale to our customers, either via a specialty distributor or through white bagging, which is when a specialty pharmacy acquires a product instead of the physician or center, and the product is delivered to that setting by the specialty pharmacy. For those that choose to buy and bill and it is covered by insurance, they can order from our specialty distributor. For those where white bagging is preferred or mandated, drug can be acquired via specialty pharmacy. 14 days of potential travel to and from an infusion center could be quite a burden on patients and their families. Where an alternate site of care is appropriate, we plan to have two other options. One is all 14 days in their home through home infusion as delivered by our specialty pharmacy partners. Determining who our specialty pharmacy partners were going to be was critical to us. They needed to specialize in pediatric home infusion and be able to service all 50 states in the country. We believe this option will be of great benefit to patients in reducing the burden of 14 consecutive days of infusion. For those who may feel most comfortable starting their course of therapy in the hospital, outpatient, or infusion center setting and then transitioning to home infusion, we have planned support for that as well. This could be done a couple of different ways. The specialty pharmacy could acquire the 14 days of therapy, ship vials to the infusion center for the approved number of days, and then deliver the remaining vials for the remaining days at the patient's home. If an infusion center does not allow for white bagging, through our controlled distribution model managed through our hub, an infusion center will be allowed to order the exact number of vials needed for a patient for the initial set of days on that side of care, and a specialty pharmacy will then acquire the remaining number of vials to be delivered through home infusion. We know it is not common for 14 consecutive days of infusion therapy or switching sites of care over a day and not a week or a month, but we have taken what we have learned from the market and our research to create a model that we believe meets our stakeholders' needs and provides flexibility to our patients and providers. To close this section out, I'd just like to say, our commitment is to support our patients and reduce the burden of treatment as much as we compliantly can. Our remit is access. Striving for payer coverage, being able to help get drug to where patients and providers need it through our limited distribution model, and helping eligible patients navigate this journey and reduce their financial burden when we can. Now I'll turn it back over to Jason, who will close us out. Thank you, Jessica. I hope that throughout the presentation this afternoon, you've seen the importance of these four strategic imperatives for launch and have a good sense of how we strategically plan to ensure that we deliver on all four. Today, you've had a chance to meet the amazing leadership team that will be responsible for driving these efforts at Provention Bio. While a tremendous amount of work has gone into getting us to where we are today, poised to hopefully help as many stage two patients as possible later this year, we still have a lot of work to do. Building a nascent market takes time, and we have the right plan in place to leverage the catalytic potential that a product like teplizumab can bring to hopefully usher in a new era in T1D diagnosis and treatment. I'd like to thank Dr. Simmons for a terrific talk and for being with us today to share her KOL opinions regarding screening and what a delay in T1D would mean to patients and healthcare providers alike. With that, we'll be glad to take some questions. We are now gonna begin our question and answer session. As a reminder, to submit a question, please use the Submit a Question tab on the top bar of the webcast portal. We do have quite a number of questions that have already been submitted since the discussion began. A number of those follow similar themes, so I will do my best to capture all these fully for our panel. Lastly, we do hope to answer as many of these questions as we can. However, if we do run out of time, we will follow up with each of you individually to answer your questions. Our first question is submitted as directed towards Dr. Kimber Simmons. You noted during your talk that you currently have 55 stage two patients at Barbara Davis. How do you intend to approach these patients to offer treatment if teplizumab is approved? For example, will you be proactively calling them in? Sure. We currently have a list of research participants and clinical patients that are in stage 1 and stage 2 of type 1 diabetes. When a new research trial is available, our teams always proactively reach out to eligible participants. I anticipate that once a commercial product is approved, that we will reach out to these eligible patients in a similar way and make them aware of a new treatment option and provide support. Thank you, Dr. Kimber Simmons. There was also a follow-up to this question. For the greater than 100 stage 1 patients that you noted, how do you intend to monitor these patients any differently with the availability of an approved therapy? We will continue to follow our protocols that are already in place and have been successful over the last several decades. We proactively reach out to people who come in for regular glycemic measurements and symptom assessments every six months on average. Sometimes very young kids may be seen more frequently, so we will continue to do this when something is approved in the future. Thank you. The next question submitted is also addressed to you, Dr. Simmons. With an approved therapy, will you be offering screening to family members of T1D patients earlier? And if so, do you have any thoughts on how long it would take to screen more of these familial relatives which have yet to be screened at your center? We currently put screening information in all of our new onset education folders that families take home. Physicians doing what we call the doc talk when a patient is diagnosed often mention screening, but really delay a further discussion until the one-week follow-up class that we have where there's a session on type 1 diabetes research and screening is highlighted. If a treatment is approved, and since screening for first-degree relatives is recommended even outside of a research setting right now, I would see this being a bigger point during new onset education, especially because siblings are often present for education and could be screened at that time. Word spreads really fast in the type 1 diabetes community. Many of our families in Colorado are connected via a Facebook group page, and I anticipate that word would spread in this way, as well as through JDRF and other organizations that have regular contact with our new onset families, and not only our families, but also new onset families nationally. Thank you, Dr. Simmons. Our next submitted question is posed to the company. How many patients, in your estimation, have already been identified, screened, and are potentially waiting for treatment? Yeah, thanks for that question. You know, this is a question that we've gotten in the past, and I think, you know, as a starting point, I'd like to refer back to something that Dr. Simmons said so eloquently in her talk, that currently today, screening is taking place in multiple settings, right? We know that they're available through commercial labs like Quest and LabCorp, through academic consortia like TrialNet and the ASK program for population-based screening, centers of excellence like Barbara Davis and others, as well as the home tests like JDRF's T1Detect. Unfortunately, in the type 1 diabetes space, there's no one universal registry for patients with early-stage disease like you see in some rare genetic conditions. However, as Dr. Simmons you know, also mentioned during her talk, institutions individually are following these early-stage patients. In the case of Barbara Davis, greater than 100 stage one and 55 stage two, and monitoring them with a specific cadence, as Dr. Simmons just said in her response to that last question, that every six months they're coming back. We also know from publications like one from Dr. Simmons about the TrialNet identification, that by 2017 they had already identified over 4,500 patients with 2 autoantibodies. The way we're approaching this is that this is gonna be more of a local practice approach to eligible patient identification, activating their lists of patients as Dr. Simmons had indicated they would at Barbara Davis. That as she also mentioned, that advocacy groups, academic consortia, physician societies like ADA will also play a critical role in getting the word out. We, you know, as we mentioned in the prepared remarks, we also see teplizumab as a catalytic agent for change in the way that type 1 can be treated and detected. With that, why don't I turn things over to Jason Hoitt first to maybe talk about how from a marketing perspective, we see teplizumab catalyzing screening and the timeframe with which we have the potential to do that. Maybe Rob Adamoski can weigh in from a medical perspective, what he's hearing from some of the KOLs and physician societies. Jason? Thanks, Jason. As I had said in my prepared remarks, everything we've heard both qualitatively and quantitatively leads us to believe that screening will increase quickly should teplizumab be approved. We're excited to have seen that 92% of pediatric endocrinologists say they will increase screening based on seeing the teplizumab target profile. For me, though, more telling number is the stark increase in screening that those who are not testing today reported. Of course, having 89% of consumers reported that they will accept screening if their HCP recommends it, continues our optimism that we will soon arrive at a new normal. Let me hand it over to Rob to talk more from the medical affairs side. Thank you, Jason. Yeah, from a medical perspective, I'll address this through the lens of both the key opinion leaders, the T1D community, and also work being done outside of Provention Bio that's fostering broader screening. First, based on feedback from numerous key opinion leaders and iterated by Dr. Simmons, the most significant barrier to broader screening today is a lack of a therapeutic intervention. If a treatment for T1D is approved and available, we believe this will further catalyze screening. We believe the same principle applies to individuals with family history of T1D. If a treatment is approved and available, this may reduce the stress of screening and allow them to discuss intervention and care plan options with their doctor. Finally, there's significant work being done outside of Provention Bio by JDRF, the Helmsley Charitable Trust, who are bringing together key stakeholders from academia, government, and medical societies to create a roadmap for population T1D screening. We believe these types of stakeholder screening efforts, data from various T1D screening studies in the U.S. demonstrating the benefits of screening, availability of lower cost autoantibody testing solutions together with a treatment option, if approved, are key catalysts that will further accelerate screening. Jason, back to you. Our next question is posed to both Dr. Simmons and the company, so we'll go with you, Dr. Simmons, first. Can you provide your thoughts on the 14 consecutive day infusion? Can you just discuss the preparations that are being done at your center to help patients and facilitate that 14-day treatment? Sure. The infusion day itself is actually not that long, and in our experience, people that we've seen get this medication through clinical research have been able to successfully carry on with their normal activities throughout the infusion period. I think one of the real challenges is that 14 days falls over weekends, and at the Barbara Davis Center, we're fortunate in that we have an infusion center in our building that we may be able to utilize for infusions of an approved medication. Importantly, we've also been talking with Children's Hospital Colorado as they are our partner hospital and have outreach clinics throughout the region that could cover a larger geographic area for infusions. We've been talking with their team, their whole infusion center team, and the nurse manager for that team is currently committed to working on a plan for how infusions could be successfully administered over the weekends if a therapy is approved this fall. Thanks. The follow-up to the company is, you know, how do you plan to navigate any of the logistical hurdles of a 14-day consecutive day infusion? Yeah. You know, as we mentioned in the prepared remarks, this barrier isn't surprising. This is something that we've heard since the early days of our market research over two years ago. It's something that we've been planning for. You know, one thing I'll just add before I turn it over to Jess to be able to address. How we're approaching these logistical hurdles is that, you know, what Dr. Simmons just highlighted, I think is very consistent with what we're hearing in the field from our field medical scientists and from some of the profiling efforts that we've been doing with many centers of excellence. Jess, do you want to just quickly re-review some of the approaches that we're implementing to minimize as compliantly as we can? We're minimizing barriers in a compliant way. Can you please address that? Sure. I hope that as part of my presentation, what we plan for in our limited distribution model and the support for those infusion scenarios show how seriously we're taking this, and know how much of a burden it could be. I guess I would just add that the beauty of the model that the team has built is really built to address all of those barriers from what we've learned so far, as Jason was just mentioning, but it's also flexible so that we can adapt as we need to if we see that there are needs that arise that we haven't prepared for. I think we feel pretty confident with what we've put together so far. Thanks, Jason. Our next submitted question is addressed to the company. How soon after the approval will you be able to start processing patients? Yeah, another great question, and I'm gonna turn it back to Jess to talk about patient services readiness in a second. I think, you know, overall, from a corporate perspective, our intent is to get drug into the channel as quickly as we possibly can after approval. You know, as a patient, as a patient-centric company, we feel our obligation is to make this drug available as quickly as we possibly can after approval because we know some patients are waiting. The specific timing, though, will be dependent on when we have sign-off from FDA on our vial and package labeling so that we can print and get the drug into the channel. As Chris mentioned during his talk, we have, you know, 12 pilot salespeople out in the field that have been doing a really amazing effort at profiling key accounts and educating around disease state and screening options. This team will be available and ready to reactively and to some degree proactively start promoting right after approval. As Chris mentioned, you know, our full sales team deployment won't be until Q4. Demand, true demand generation won't start until Q4. You know, Jess can talk about from a patient services perspective, what specifically we'll have available and when. Jess? Thanks, Jason. We know that some payers may make coverage decisions pretty quickly after approval. Our goal is to make sure we are ready to support patient access on day one. We're planning to have April's patient services program up and running on day one of approval, which is gonna mean that the navigator team's gonna be there, trained, and ready to accept and process enrollments on day one, as well as work with those eligible patients regarding financial assistance. We're also gonna have our clinical educator team trained and ready to support any infusion training that centers or staff may request. Our next question submitted is also addressed to the company. What do we expect the biggest payer challenges to be, and what will payer coverage look like upon approval and launch? Yeah, this is a great question. You know, one thing that I love about the feedback that we're hearing from payers that I think Jessica highlighted really nicely in her prepared remarks is just the consistency of the feedback that we've heard since we started engaging with this key stakeholder audience over two years ago. You know, we know though that discussions will change once we have a final label and we've announced a price, which won't come until after approval. Jessica, do you wanna talk about from a payer perspective what you anticipate challenges to be and how we're gonna anticipate those and work to rectify or mitigate any challenges? Sure. I think it's great timing too. We recently did some payer focus groups, and we're able to ask some specific questions around challenges. A couple that we heard were concerns over an FDA approval based on a phase 2 trial, also needing to understand the use of PK modeling to address why the likely changes in our dosing in an approved label would differ from what was seen in the TN-10 trial. I'll say that even as the concerns were articulated, we figured out with explanation and education in those sessions, every participant in those focus groups stated that they would cover the product. Of course, as Jason just mentioned, final label and final price could change things, but as it relates to preparation so far, we feel pretty confident there. From a timing at launch perspective, while the overall majority of signs have been positive, we know it can take some time for medical policy to be formalized, and certain Medicaid states are gonna wait until mandatory coverage is required. That said, we do expect to see coverage by medical exception initially, commercial payers publishing policies for the most part within the first 3-6 months, and Medicaid coverage coming on after that. Thanks, Jessica. Another question, addressed to the company. Can you reiterate again and go over the plan composition for the sales team? Importantly, talk about the overall hiring climate right at this juncture. Thanks for the question. Let me address the hiring climate first. As I mentioned in my previous remarks, we have had the benefit of many potential candidates for the sales team proactively reaching out to us because of their personal connection to T1D, including some that are T1D patients. We have also had many candidates who have worked with one or more of the current team on rare disease and endocrinology products previously. To reiterate, the team will be 60 therapeutic specialists reporting to 8 regional sales directors who will report in to me. You know, based on time, I think we have time for maybe one more question. I do wanna note, you know, thank you to so many who have submitted all these questions, and we're able to track them, and we'll be able to get responses to you guys in short order. But this is the last one we can get to today. Also for the company. How might positive data from the PROTECT trial potentially expand the addressable market? Yeah, you know, it's a good question. You know, as I mentioned in my prepared remarks, you know, this at-risk initial at-risk indication, if approved, we see as the foundation of a potential franchise built around this asset. You know, with that said, if there's a positive readout from the PROTECT study and it leads to the approval of our second indication, we see this expanding the addressable market to newly diagnosed patients, which from an addressable market perspective, opens about 64,000 individuals that are newly diagnosed in the U.S. each year. I think what's also important is the synergies that exist between the physicians that will be treating at-risk patients and the physicians that could potentially be treating newly diagnosed patients. You know, it's the same group. It's a group that we will have been interacting with for, you know, a, you know, a period of time based on the at-risk launch, assuming we get approval in August. Thank you again for all your participation today and for submitting all these questions. I also want to highlight a thank you to Dr. Simmons for joining us and sharing her insights with all of us today, as well as our team. This brings us to the end of the event, and we look forward to keeping you all apprised as we continue to the potential approval and launch of teplizumab later this year. Enjoy the rest of your day. Thank you.