Welcome everybody to the 40th annual J.P. Morgan Healthcare Conference. My name is Anupam Rama. I'm one of the senior biotech analysts here at J.P. Morgan. I'm joined by Priyanka Grover, Malcolm Kuno, and Caleb Smith from the team. Our next presenting company is AlloVir, and presenting on behalf of the company, we have CEO Diana Brainard. I want to remind everybody that there is an ask a question feature in the portal. If you would like me to ask a question on your behalf, please feel free to put it in the portal, and I will do so. With that, Diana, you take it away. Great. Thanks so much, Anupam. Great. Well, I'm delighted to be here as CEO of AlloVir and thrilled to share an update on the incredible progress we've made over the last year, advancing our pipeline of allogeneic off-the-shelf virus-specific T cells. I want to start on slide three by walking through a few key numbers that help summarize who we are today. AlloVir first has a rich pipeline with four investigational virus-specific T cell therapies, or VSTs, targeting 12 different viruses that could lead to approvals in seven distinct indications with high unmet need. By the end of the first half of this year, we'll have three ongoing phase III registrational trials for posoleucel, our lead candidate, which has received five special regulatory designations that facilitates frequent interactions with both FDA and EMA. We now have 69 clinical trial sites open across North America, Europe and Asia. We ended 2021 with just over $248 million on our balance sheet, which is enough to carry us well into 2023. Moving to slide four. AlloVir is a leader in allogeneic off-the-shelf VSTs for the treatment and prevention of viral diseases. We have a clinically validated approach to treat viral infections with posoleucel in immunocompromised patients and have seen greater than 90% efficacy in our phase II CHARMS study with posoleucel. More broadly, our platform has enabled us to build out a pipeline of candidates that target 12 different viruses with four different products. Right now, our current trials are focusing on stem cell and solid organ transplant patients. Our platform and our pipeline have the potential to expand to address the unmet needs of additional patient populations and will plan to move into those populations in the future. Importantly, our manufacturing process is simple. We have built redundancy into our manufacturing and supply chain through key partnerships and have a line of sight to commercialization and distribution of our cells globally. It's based on the footprint of our clinical trials. Moving to slide five. I want to start on the left-hand side, where you can see the significant challenges that immunocompromised patients face when confronting these devastating and often deadly viral diseases. Transplantation, immunomodulation, chemotherapy, and even the extremes of age can all create vulnerability to viral infections that wouldn't necessarily pose a problem to someone with a competent immune system. The majority of these viruses have no approved therapies, and cumulatively, they have an enormously negative impact on patient outcomes, from prolonged hospitalization to end organ damage to death. Our approach at AlloVir has been to restore the T cell defect that is leading to disease in the first place and to target multiple viruses to enable both treatment and prevention in high-risk populations. In this way, we envision having a truly transformative impact with our VSTs. We have confidence in our approach because VSTs have been used in select high volume academic stem cell transplant centers for more than 25 years, providing a solid foundation for their potential. At AlloVir, we've accelerated beyond the bespoke approach of autologous single virus treatments at these academic centers to create a scalable platform of products targeting multiple viruses with allogeneic off-the-shelf products that can be made available to patients within 48 hours. As I move to slide six, you can see an overview of our highly innovative approach. Our scientific founders gave the first VSTs to patients many years ago, and their decades of experience have enabled us to build an industry-leading VST platform that begins with the selection of the appropriate antigens to target for each virus. Our manufacturing process is simple. There's no gene editing and only a single round of expansion. Our cells are generated from healthy donors with immunity to all of our target viruses. Cells from unique donors undergo expansion in the presence of a patent-protected peptide and cytokine cocktail that generates T-cells with a high degree of polyclonal and potency across all of the target viruses. This process can prospectively produce cell banks that cover more than 95% of the population from a relatively small donor pool. We have long-term stability enabling us to cryopreserve these cells and then deliver them when needed to patients within 48 hours. Moving on to slide seven. You can see that our pipeline targets 12 unique viruses with four allogeneic off-the-shelf VST therapies that are designed to treat or prevent life-threatening viral diseases that have severely limited or more commonly, no approved treatments. Our lead investigational therapy, posoleucel, is a pipeline in a product. As a multi-virus specific VST, we can pursue multiple indications with posoleucel. This is truly unique, and it's a differentiated approach that gives us the transformative potential for patients, particularly when it comes to prevention. Beyond posoleucel, our pipeline includes the investigational multi-respiratory virus product, ALVR106, for the treatment of RSV, influenza, parainfluenza, and human metapneumovirus, which collectively incur substantial morbidity and mortality in immunocompromised individuals. We recently announced that our proof of concept study for ALVR106 in stem cell transplant patients is now open for enrollment. Our pipeline also includes ALVR107, an investigational therapy that's preclinical for hepatitis B cure. Finally, ALVR109, our SARS-CoV-2 targeted VST, which has shown promise both in a phase IB clinical trial and in the compassionate use setting where it's been used in immunocompromised patients who are not served by currently available therapies. With the polyclonal nature of our VSTs, we've been able to demonstrate that ALVR109 retains potent antiviral activity against all the variant strains of SARS-CoV-2 that we've tested to date, including Omicron. Moving to slide eight. Here we show the data from the phase II CHARMS study of posoleucel, which has driven the rapid progress of our clinical programs. The CHARMS study demonstrated a 93% response rate across 58 evaluable patients who were treatment refractory or resistant. The strength of these clinical data led us to receiving RMAT designation for both virus-associated hemorrhagic cystitis and more recently, adenovirus, and PRIME designation from EMA, and enabled us to advance into our ongoing phase III registrational trials for these indications. As I believe most of you know, in healthy individuals, T-cells from the body's natural defense system provide protection against many viruses. For patients with T-cell deficiencies, viruses may be uncontrolled, leading to potentially devastating and life-threatening consequences. Allogeneic stem cell and organ transplantation conditioning regimens often require the elimination or abrogation of a patient's own immune system, leaving them in a severely immunocompromised state. As you can see on slide nine, with stem cell transplant recipients, the first 100-180 days post-transplant is a particularly vulnerable time. Their own immune system has been ablated, and yet the transplant has not fully engrafted. It's in this window of time when we see significant reactivation of single or multiple viruses. For 90% of allogeneic HCT patients, their suppressed immune system allows viruses that were previously latent to reactivate. More than 60% of these patients will reactivate more than one potentially fatal virus. It's in this window of susceptibility that we see a significant need for new options to not only treat these viral infections, but if possible, prevent them from occurring in the first place. Posoleucel is designed to restore immunity during this time of severe immune compromise. When given as prevention, may substantially reduce or prevent virus-associated morbidity and mortality, and dramatically improve patient outcomes. This is exactly the hypothesis we set out to test in our phase II proof-of-concept multi-virus prevention study. Moving to slide 10. We recently shared the exciting, positive initial efficacy and safety data from the ongoing multi-virus prevention phase II study at ASH last month. As you can see, we presented preliminary data on the first 23 patients enrolled who had received at least a single dose of posoleucel. We observed very low rates of clinically significant infections to date, well below what we see in the literature and electronic medical record analyses. Importantly, no patient developed end organ disease during the first 14 weeks covering the dosing interval or in the follow-up period out to week 26. For prevention, we administer posoleucel every two weeks for a total of seven doses. Our safety profile with this dosing regimen was very encouraging. No unanticipated safety signals emerged, and rates of graft versus host disease were consistent with what we'd expect in this high-risk post-transplant patient population. Infusions were generally well-tolerated, with no cases of cytokine release syndrome. The possibility of preventing multiple common devastating viruses with a single therapy could be truly transformational for the field of stem cell transplantation. This is why we were so pleased with these initial data. Based on the high unmet need in this patient population and the strength of these data, we were also able to reach agreement with FDA on a path to move directly to a registrational phase III study as our next step. With compelling posoleucel phase II data now in both treatment and prevention of multiple target viruses, we're thrilled to execute on our registrational trials and in parallel, expand beyond stem cell transplant patients into other immunocompromised patients, such as solid organ transplant recipients. As I move to slide 11, you can see the momentum we have with posoleucel, our pipeline within a product. Studies are underway or planned for five distinct indications across stem cell and solid organ transplant recipients. I'm now going to spend a few minutes walking you through our ongoing studies. On slide 12, you can see the design of the registrational phase III trial of posoleucel for the treatment of virus-associated hemorrhagic cystitis, a well-described complication after stem cell transplant that has no approved or effective treatment options. Published data demonstrate that patients with virus-associated hemorrhagic cystitis have a 70% higher risk of mortality than those who don't develop this complication, and that this disease is associated with significantly prolonged hospitalization, including increased intensive care unit stay, as well as higher hospital readmission rates once patients are discharged. Based on the strength of the phase II CHARMS treatment data in the subset of patients with virus-associated hemorrhagic cystitis, we were able to work quickly with regulators in the U.S. and globally to establish the design of this double-blind, placebo-controlled phase III study in which 125 patients with grade 3 or higher macroscopic hematuria will receive posoleucel or placebo. The primary endpoint in this study is time to resolution of hematuria, which is a clinically meaningful endpoint that links directly to the CHARMS data and the potential benefit that posoleucel can bring to patients with this devastating viral disease. The study started last year and continues to enroll patients with European and Asian sites recently coming on board. We expect to complete enrollment of this trial in the first half of next year. Moving to slide 13. Adenovirus infection can be life-threatening, particularly for children, and it has no approved treatments. It's therefore a dreaded complication of stem cell transplantation, with reactivation occurring in up to one-third of all pediatric allo-HCT patients. Last week, we announced that not only have we started our phase III registrational study of posoleucel for the treatment of adenovirus infection, we also received RMAT designation from FDA. This study will enroll 80 allo-HCT patients with high level viremia or with a consistently rising viral load. The primary endpoint is reduction in viral load at week four, with both clinical and safety outcomes being followed out to week 24. We look forward to accruing patients into this important study in both the U.S. and Europe this year and are excited at the possibility of patients and the transplant community finally having a treatment option for patients with this devastating viral disease. A few slides ago, I shared with you the exciting preliminary phase II prevention data that was presented at ASH last month. We provided these data to FDA and as I mentioned, gained agreement in principle to proceed directly to a phase III registrational trial as the next step. With enrollment of the open-label phase II study now complete, our next step is to submit the phase III protocol to FDA for their review, which we'll do in the near future. We've already received high-level feedback and input on the study design, which is shown here. High-risk allo-HCT patients will be randomized to receive posoleucel or placebo infusions every two weeks for 12 weeks. The dose and dosing interval will be the same as was studied in our phase II trial, and the primary endpoint remains the same as well, the number of clinically significant infections or episodes of end-organ disease through week 14. This study will enroll high-risk allo-HCT patients who represent about 75% of the total allo-HCT population, and it's clearly the most disruptive way of using a multi-virus-specific T-cell therapy. This approach has the potential, if successful, to transform the patient journey post allogeneic stem cell transplantation and eliminate much of the risk from the complications of these six devastating viral infections. As I mentioned earlier and shown on slide 15, we're also studying posoleucel in the solid organ transplant population. These patients, although they have a different type of immunosuppression than stem cell transplant recipients, they also suffer from viral reactivation and the negative health consequences that can impact the survival of their transplanted organ as well as their overall health. Our proof-of-concept phase II study of BK viremia in kidney transplant recipients is shown here and is ongoing. We recently looked at a blinded data set in order to submit an abstract to a scientific conference occurring later this year. Based on these initial encouraging safety data and with support from our lead investigators and data and safety monitoring board, we've amended the study to open it up to patients with higher viral loads who are at the higher risk for advancing to overt BK nephropathy, which can decrease kidney graft survival, leading to a return to end-stage renal disease and dialysis. Later this spring, we look forward to presenting a larger, unblinded data cut from this study, which will inform our next steps in this population, as well as more generally in solid organ transplant recipients overall. Slide 16 illustrates the commercial opportunity that we see for posoleucel. Based on the launch of the three indications for which we'll have ongoing phase III registrational trials in 2022, the treatment of virus-associated hemorrhagic cystitis, the treatment of adenovirus, and the prevention of six viruses in stem cell transplant patients. We estimate that there are nearly 40,000 patients annually who could benefit from posoleucel. This alone is a blockbuster market opportunity, and posoleucel would be the first approved therapy for each of these indications. Expanding into solid organ transplant recipients substantially increases the addressable patient population by over 100,000 patients. Taken together, treatment and prevention indications in both stem cell and solid organ transplant patients total approximately 150,000 addressable patients annually. It's important to recognize that this is incidence rather than prevalence in terms of the number of transplants performed each year. As our safety and efficacy data grow with our VSTs, we're also evaluating additional opportunities to study posoleucel for other patient populations that can expand the eligible populations even further. I spent a lot of time talking about our top priority, where we're laser-focused on execution, our lead product, posoleucel. I also want to briefly share an update on our two investigational therapies that are advancing into the clinic this year. As you see on slide 17, ALVR106 is a multi-respiratory VST therapy in development for the treatment of human metapneumovirus, influenza, parainfluenza, and RSV. We announced last week the initiation of a proof of concept study of ALVR106 in stem cell transplant patients, and we plan to expand into the high-risk general population in the future. With ALVR107, we're on track to initiate a proof of concept phase Ib study at the end of this year in patients with chronic hepatitis B as we look to use our VSTs to cure this condition. To close, I want to highlight why 2022 is poised to be another important year for AlloVir and our platform. You can go to slide 18. Our lead asset, posoleucel, which targets six devastating viruses, will be evaluated in three phase III studies in three distinct indications for stem cell transplant recipients. Two of these phase III trials are already ongoing, and one study, our third phase III in prevention, will begin by the end of the first half of this year. In addition, we'll be presenting our first data in the solid organ transplant patient population, a really critical patient population that's large and has a huge unmet need for successful broad-spectrum antiviral approaches. We continue to develop and advance our rich pipeline of virus-specific T-cell therapies and are advancing our two additional products through the clinic this year. Importantly, FDA and EMA have both recognized the potential of our medicines through the high caliber regulatory designations we've received to support the development and review of our product, posoleucel. All of this work that we've done to date and continue to do is led and supported by a highly experienced and proven management team that has collectively developed some of the most successful and impactful therapies of all time. We're thrilled to be where we are today and committed to executing on our ambitious clinical and commercial goals here at AlloVir. With that, Anupam, I'll turn it back to you to kick off the Q&A. Thanks. Great. Diana, if you wanna introduce the broader team that's on the line. I do. Yeah. Great. Thank you. I'm joined here on the call with our President and Chief Financial Officer, Vikas Sinha. We've also got Ann Leen, our Chief Scientific Officer and Co-Founder, and Jeroen van Beek, our Chief Commercial Officer. Maybe I'll start the discussion with, you know, ASH was live this year, but, you know, many of us weren't at ASH. Maybe you could provide some physician feedback on the prevention data that you got? In your presentation, Diana, you talked about how the infection rate that you're seeing is better than what you see, you know, in the literature. Like maybe put that into context of what are the reference benchmarks and whether it's letermovir or otherwise? Yeah. Great. Thanks, Anupam. That's a great place to start. You know, I think that the reception from the physicians in the community at ASH and also in the follow-up calls that we did with investigators and people also wanting to subsequently participate in our studies was overwhelmingly positive. I mean, people recognize there's an unmet need for these viral infections because there are so few treatments available. I think, you know, really seeing the data for the first time, showing the prevention across six different viruses, at least in this preliminary data set, was so strong. Comparing that to what people expect to see that benchmark. We didn't have an internal control arm for that study. We looked to the literature. We looked at electronic. More recent electronic medical records analyses to ask the question, if untreated, how common would these clinically significant infections be? We get to a number of around 70%. What we saw in our trial was well below that. It was about 13% in this preliminary data set. What we had heard from physicians was, you know, letermovir is working well, and we're happy with it. It reduces the rate of CMV infection alone by about 50%. It reduces it about half. If you can do that, but do that across six viruses, you've got a home run. We were clearly able to show that we're doing that and more. I think that was why the reception was positive, and that's part of the reason that we were able to gain traction with FDA on getting this fast forward to phase III. What are the final sort of details that need to be ironed out with the FDA to start that pivotal study in prevention and thoughts about size of the study? You know, if I wouldn't quote me on this, but I think those letermovir trials were the prevention study was, like, 500 or 600 patients. Like, what do you actually think about that? I mean, what we're thinking about is, you know, doing a study that's bigger than the other treatment studies that we have ongoing, because instead of addressing one virus, we're addressing multiple viruses. We wanna make sure that we've got a large enough sample size that we can show adequate numbers and prevention across our different target viruses. Our study's gonna be on the order of several hundred patients. We wanna get feedback from FDA on that. That's one of the details. You know, really the missing piece is we need to send them the protocol and get feedback on the protocol. The high level pieces we feel like we've got an agreement from them based on our written interactions with them. It's always in the details around sample size and assumptions that you wanna make sure that they're on board before kicking off the study officially, and that's a really important step for us. I don't think we need to go as large as a small molecule, the letermovir study, to be honest. Based on the powering, based on the treatment effect that we're seeing, we've got a lot of room to move there to you know to do something that's bigger than our treatment studies, but not as big as letermovir. Yeah. Okay. In your presentation, Diana, you talked about some preliminary data here in the first half of 2022 in BKV virus transplant patients. I guess we should maybe walk us through the size and scope of the data and what you think would be a win scenario when we flip that card? Yeah. Well, I think, you know, the, it's important to remember that stem cell transplant physicians, they're very comfortable with cell therapy. They've been familiar with VSTs for a long time. They're used to seeing data presented from Ann Leen and her team at Baylor, from MD Anderson Cancer Center, from Cincinnati Children's Hospital Medical Center, looking at, you know, small center results. They feel comfortable with this modality. They also use other types of cell therapy routinely in the treatment of their patients. In solid organ transplant, this is a relatively new modality for them. The biggest hurdle for us is education and demonstrating safety. That's why we started the BK Virus Nephropathy study in the low viral load patients. It's based on feedback from physicians that they really wanted us to demonstrate there wasn't gonna be some kind of unexpected untoward effect. We're very happy that we can now open up the trial to these higher viral load patients. I don't wanna disclose any data that's under embargo, but just to say that, you know, we have made that change, which will be reflected in ClinicalTrials.gov in the near future if it's not posted already, to open up that study. I think generating and sharing that safety data with repeat administration in these patients is number one. Then secondarily, it's also important to show antiviral effect. With BK viremia, you're not talking about that long-term impact of graft survival. That's something that is gonna take a longer study to demonstrate. But what we're talking about is modulation of the, you know, the viral load and dampening the curve, so to speak. That's something we look forward to sharing, hopefully, you know, in the spring at a major scientific congress. Got it. Maybe talk a little bit about the decision to move away and deprioritize CMV with posoleucel. I mean, I get that there are other treatments out there, but, you know, with some of the persistency of effect that we saw at ASH, particularly in prevention, like, was that not considered, or how do we think about that? Yeah, absolutely. I'll ask Jeroen to comment as well because he's done a lot of outreach too with physicians. I mean, I think the issue, Anupam, is it was less a pivot away from CMV and more of a recognition that we're going to be capturing these patients in our prevention study. You know, when we think about how physicians think about CMV, right now, they're thinking about the highest risk adult patients get letermovir for 100 days per the labeled indication. Everyone else, they're monitoring very, very closely, including the letermovir patients for breakthrough. They're starting CMV preemptive treatment with valganciclovir, sometimes foscarnet, when the viral loads reach a certain threshold. You're not seeing a lot of end organ disease with CMV. You're not seeing a lot of refractory or resistant CMV. It's becoming less and less common, because people are very aggressive about screening to avoid it. In our prevention study, where we're allowing patients to enroll who are aviremic or who have viremia just at low levels, we realized we're gonna be capturing, and we think preventing the vast majority of CMV end organ disease. Therefore, a CMV standalone treatment trial isn't gonna make a lot of sense. Then particularly in the context of maribavir just being approved and people not really sure how that's gonna impact the standard of care, we just thought it made sense to put our resources and double down on prevention and then decide down the line, is there a real need for a treatment trial? If so, we can do it. Okay. Maybe talk a little bit about manufacturing. Where is posoleucel manufactured currently? What are the long-term manufacturing plans for the product? Yeah, absolutely. I think, you know, Vikas brings this up a lot, is that we've made a very deliberate decision to not build our own manufacturing facilities. We've got a great partner with ElevateBio. You know, in terms of having manufacturing, we work with another CDMO as well. We've got redundancy in the system without having to really pour a lot of our money into maintaining and building our own facilities. We can use our capital for our clinical trials. I think also with the experience of this management team, and this was very clear to me when I was on the board as an independent director, there's always been a focus on line of sight towards regulatory approval and putting together the pieces in place to have a CMC dossier that can withstand scrutiny for a commercial product and recognizing that things need to be put into place as you transition from an academic lab into moving towards commercialization. That work was started very early on, and I think we're very much on the right track to be where we need to be at the time that our clinical data come in and read out, and we put together a BLA. Okay. Maybe final question here. I think the presentation noted about $250 million in cash at the end of the year. Just remind us of the runway with that cash? Yeah. Vikas, do you wanna take that one? Yeah, Anupam. We have $250 million in cash right now, about $248 million, to be exact. I think we'll get well into the second half of 2023 with that money. We are focusing purely into executing the clinical trials now with this. As Diana was mentioning, we don't have to spend anything on the manufacturing plant or anything like that. It's just purely execution here. We're looking forward to moving as quickly as possible to getting these three clinical trials, especially those in phase III, at a high priority and driving it through. All right. Diana and team, I wanna thank you guys so much for a super productive session, and hope you guys have a great rest of the conference. Great. Thanks, Anupam, and thanks to your whole team and, listeners as well for joining. Bye-bye. Thanks. Thanks, everyone.