All right. Good morning, everyone, and thank you for joining us for AtaiBeckley's 2026 Investor Day. Before we begin, I'd like to remind everyone that this call and presentation will contain forward-looking statements. These statements are subject to risks and uncertainties, and actual results may differ materially. We undertake no obligation to update our forward-looking statements except as required by law. Additional information can be found in our SEC filings. With that, let's review the agenda. We are really excited to walk you through our strategy, clinical progress, and our vision for leading a new era in interventional psychiatry. Today's presentations will focus on how our lead asset, BPL-003, is positioned to deliver rapid-acting, durable, and scalable treatment options for patients with treatment-resistant depression and beyond. After a short break, we'll then turn our focus to a roundtable discussion featuring leading experts in the field, followed by a moderated Q&A with our management team and the key opinion leaders. We have a full morning plan. I am pleased to introduce Srini Rao, co-founder and CEO of AtaiBeckley, who will start the morning with an overview of AtaiBeckley's strategy and portfolio. Srini, over to you. Great. Thank you, Jason, thank you to everyone in the audience who's made time to join us today on our Investor Day webcast. At AtaiBeckley, our mission is clear: to transform mental health care by developing next-generation psychedelic-based neuroplastogens that combine rapid onset, durable benefit, and real-world scalability. We're uniquely positioned to lead this category with an approach built on four core pillars. Number 1, we focus on indications with high unmet medical need, like treatment-resistant depression, or TRD, and social anxiety disorder, or SAD. Number 2, we're advancing therapies designed for rapid-acting and durable clinical impact with the goal of moving beyond daily or frequent intermittent dosing paradigms. Number 3, we've designed our products from the outset for real-world scalability. This involves using practical and familiar routes of administration and plugging into established care delivery models. Finally, 4, we are diligent in protecting our innovations with a comprehensive IP portfolio across compounds, formulations, and methods of use. Together, these pillars define how we build, prioritize, and deliver therapies that can truly shift the standard of care and transform patient outcomes in the mental health space. On the next slide, you can see our pipeline, which spans across the TRD and SAD clinical-stage programs and also includes our emerging discovery stage assets. We will, of course, focus on BPL-003's recent progress and advancement into phase III pivotal studies for the remainder of this call. Let's take this opportunity to briefly touch on our other clinical programs, starting with VLS-01. This is a differentiated buccal film formulation of N,N-dimethyltryptamine, or DMT, that is being developed for TRD. In a phase I clinical trial, VLS-01 demonstrated a promising profile that combines a short duration of subjective effects with encouraging tolerability. We are eagerly awaiting the top-line data from the ongoing Elumina phase IIb trial in the second half of this year. I also want to talk briefly about EMP-01 and highlight the positive top-line results we announced last week from an exploratory phase IIa trial in SAD. What really sets EMP-01 apart from racemic MDMA is its unique pharmacology. By eliminating the S-enantiomer of racemic MDMA, we reduce the stimulant activity and strengthen serotonergic effects. As we mentioned last week, the exploratory phase IIa study, the first of its kind in general SAD with a psychedelic compound, met its primary endpoint on safety and tolerability, and moreover demonstrated very encouraging early signals of efficacy. The consistent gains across secondary and exploratory endpoints, combined with a differentiated subjective profile, provide meaningful validation of both of the compound and our development approach. Taken together, we are very proud of our leading portfolio of three high-potential clinical assets and conditions with large unmet medical needs. Let's go on to the next slide. Depression and anxiety represents some of the most prevalent and burdensome mental health conditions globally. In the U.S. alone, more than 20 million adults experience major depressive disorder each year, and over 30 million experience social anxiety disorder across their lifetime. These are massive patient populations, more importantly, they are populations where treatment innovation has lagged. The opportunity is significant, as we'll discuss, we believe our clinical and commercial strategies are aligned to capture it. On the next slide, we expand on the unmet needs that continue to define the mental health landscape. Despite decades of available treatments, the reality is that many patients are still left without symptom relief for their mental health conditions. Most current therapies often take weeks to work, if they work at all. Many require chronic daily or intermittent dosing that is often associated with undesirable side effects that many patients simply can't sustain. The burden is real, and it manifests both clinically and economically. What's becoming increasingly clear is next-generation therapies must do more than merely suppress symptoms. They need to meaningfully reset the underlying circuits that drive these conditions to thus provide long-lasting benefit. That's exactly the gap that psychedelic based neuroplastogens aim to fill. The figure on the next slide lays out the mechanistic foundations behind our approach. Psychedelic-based neuroplastogens activate pathways that promote synaptic regeneration and neurogenesis, but they also disrupt maladaptive brain network activity. You can think of it as helping the brain escape entrenched patterns that often underlie treatment-resistant mood disorders. The acute biological effects are associated, of course, with a unique subjective experience. Beyond psychedelic phenomena, this experience may involve emotional release, perceptual shifts, and cognitive reframing. Together, this combination of mechanistic neuroplasticity and the associated subjective experiences are thought to underlie the rapid benefits seen with these compounds. This dual mechanism also seems to open a longer period of behavioral plasticity that in turn drives durable efficacy. This durability is critical to making intermittent dosing feasible. The shift to intermittent dosing promises to fuel the next phase of change and growth in the field of interventional psychiatry. The next slide outlines the progression of interventional psychiatry from devices like rTMS to pharmacotherapy, starting with Ketamine and then on to Esketamine. These compounds represented a paradigm shift for the space when they were first introduced, as they were the first drugs to offer rapid symptom relief. However, they lack durability and thus require frequent re-dosing. First-generation psychedelic products based on psilocybin or LSD offer both rapid onset and durability. However, both require many hours in the clinic. This markedly increases complexity, limits scalability, and increases the burden on patients. This leads us to second-generation psychedelic-based products, the space where AtaiBeckley leads. Both BPL-003 and VLS-01 were purposefully designed for short, scalable in-clinic sessions. We've essentially taken the lessons from earlier interventional approaches, including Spravato, and designed treatments that retain or possibly even improve upon efficacy while dramatically reducing complexity. This shift is foundational as it allows clinics to deliver high-impact treatments without sacrificing capacity, and it makes these therapies accessible to many more patients. The next slide highlights this core pillar of our commercial differentiation strategy. J&J has built the infrastructure that has led to Spravato's commercial success, with thousands of clinics nationwide that now operate under a workflow that includes pre-dose checks, on-site administration, and post-dose monitoring. BPL-003 fits directly into that structure with a similarly short in-clinic stay and no need for psychotherapy or specialized equipment. As you can see, this is a critical differentiator from the rest of the late-stage psychedelic pipeline. The short in-clinic time allows clinics to maintain predictable patient schedules, maintain high throughput, and operate within existing staffing models. For patients, it dramatically reduces the burden of care. Instead of weekly visits, BPL-003 has the potential for four to six short treatment sessions per year without compromising efficacy. This is what scalability looks like in interventional psychiatry, and AtaiBeckley is the leader. On the next slide, I wanna highlight how the convergence of science, strategy, and timing has put AtaiBeckley in this truly enviable leadership position. The pace of progress in this field has never been stronger, and it's clear that psychedelic therapies represent the next paradigm shift in the treatment of mental health conditions. Moreover, we're at a moment where regulatory clarity, clinical maturity, and commercial precedent in psychedelic therapies are all converging. AtaiBeckley brings together the expertise, the clinical data, and the purpose-built infrastructure to lead the shift towards second-generation psychedelic therapies. This alignment positions us uniquely to shape the future of interventional psychiatry. Now on to the next slide. We have begun 2026 building upon our successes in 2025. BPL-003's breakthrough therapy designation positions us for enhanced engagement with the FDA and a potentially accelerated path towards approval. Now we've obtained alignment on our phase III program with the agency, as we'll discuss shortly. We have several important readouts and milestones ahead, including the initiation of our phase III program and additional phase II readouts across the pipeline. Following our M&A and IP expansion last year, our financing activities allowed us to end last year with just over $220 million in cash. Combined with our inclusion in the Nasdaq Biotechnology Index and successful U.S. re-domiciliation, we're in a strong position to execute. We're excited to dive deeper with you on the BPL program and our commercial strategy. I'm excited to hand this off to Kevin to go through the clinical summary of BPL-003 and the upcoming BPL-003 phase III design and plan. Kevin? Thank you, Srini. Yes, I mean, we are excited to share details about our BPL-003 program, the progress we've made so far, and the next steps to come. Many of you are familiar with the BPL-003 program, we'd like to start with an overview of the key features on the next slide. BPL-003 is an intranasal dry powder formulation of mebufotenin benzoate. It's a serotonin receptor agonist with rapid onset and a short in-clinic monitoring time. Following positive phase IIb results, where we saw rapid and durable effects after a single dose of BPL-003, it was granted FDA breakthrough therapy designation, reflecting both the strength of our data and the significant unmet need in TRD. After a successful end of phase II meeting, we plan to initiate the first phase III study in Q2 and the second in Q3 with final designs informed by FDA feedback. The FDA indicates their support for our proposed phase III program, reflecting a robust safety and efficacy profile across multiple phase I and phase II trials. In clinic, most participants were deemed ready for discharge approximately two hours after dosing, which if replicated in phase III, could support higher patient throughput in established workflows, as Srini alluded to. Collectively, the combination of a strong data package, momentum for phase III, and a convenient dosing provide a strong foundation for us to continue studying BPL-003 in the future. Before diving into the phase IIb data, I'd like to just take a step back on this slide to provide a quick background on the different routes of administration for psychedelic treatments. The treatment administration methods listed here can significantly shape a patient's clinical experience and impact how scalable a treatment is in clinical practice. Among the options, the intranasal and buccal sublingual routes align most closely with real-world treatment requirements. They're familiar to clinicians, offer convenience to patients without compromising on predictable PK and a rapid onset, which are key considerations for scalability. BPL-003 uses an intranasal route of administration, which is important for its potential to be adopted in real-world clinical settings and to take advantage of existing interventional psychiatry workflows. Now that we've set the scene, let's look at the phase IIb data on the next slide. As a whole, our phase II data created a differentiated and well-rounded profile that gives us confidence in our advancement into phase III. At a high level, we demonstrated that BPL-003 is fast-acting, durable, highly effective, well-tolerated, and convenient in TRD. In the 2b, we saw the antidepressant effects of BPL take effect quickly with significant reduction in MADRS scores. The efficacy signal proved compelling and durable, with high response and remission rates. BPL was also well-tolerated and provided convenient administration with only a 2-hour time to discharge readiness, supporting feasible real-world administration in a long-term maintenance setting. Let's walk through the phase IIb design on the next slide. Our phase IIb trial for BPL-003 was a randomized quadruple masked study enrolling patients with moderate to severe TRD. Walking from the left of the slide, eligible patients were washed out if they were taking antidepressant medications, and those that weren't were enrolled. All the patients were randomized to 1 of 3 groups, either 12 milligrams, 8 milligrams, or the control arm, 0.3 milligrams. The primary endpoint was the total MADRS score at day 29, change from baseline. We followed patients up and took MADRS scores, you know, 1 day after dosing, the week later, day 8, and day 57. That was really to establish the long-term durability of the effect. At the end of that core study, participants, who were eligible, could then roll over and move into the open label study where they could receive a single dose of 12 milligrams of BPL-003. In addition to that primary endpoint, we had secondary endpoints, which included the MADRS change from baseline, as I mentioned at day 2, week 4 and week 8, as well as the effect of 8 milligrams at week 4. We also looked at response and remission rates. The design of the phase IIb trial allowed us to measure both acute and long-term effects of BPL across the doses and repeat administrations, which provided critical insights into the timing of onset, the efficacy, and the durability. On the next slide, we see that a single dose of BPL-003 met the primary endpoint. We observed a statistically significant change in MADRS score at day 29, with effects sustained up to week 8. For the 8-milligram arm, the MADRS change was minus 12 from baseline and minus 6.2 when comparing to the 0.3 control arm. The 12 mg was 11.2 change from baseline, with a 5.3 difference compared to the 0.3 control. I wanna highlight that the treatment effect was quite significant as early as day 2, which reinforces BPL's fast-acting profile. Looking at the blue and green lines on the chart, you'll note that the 12 and the 8 doses of BPL achieve comparable improvements in MADRS. The comparability is important because especially when we consider the safety data that we will talk through later on, which favored 8 mg. That combination of similar efficacy with a favorable safety profile is the key factor behind 8 mg as the phase III dose, and I'll touch more on that in the following slides. When placed alongside external datasets for context, we're looking here at an overview of the MADRS outcomes across clinical studies in TRD, we can see that earlier time points, the change from baseline in MADRS score versus placebo or control looks similar across the COMP360 and Spravato trials. You'll note that the durability or rate of change over time is also quite consistent across the two COMP360 trials. BPL's week 8 durability appears encouraging. These are indirect comparisons and of course difficult, different study designs, so they're not head-to-head. The longer-term treatment effect looks quite different. The efficacy signal for BPL-003, shown in the green line here, remains durable to week 8. The study suggests that BPL may offer a more durable effect following a single administration. We do want to caveat that there's obvious limitations to this comparison, namely that it isn't a head-to-head study, we're comparing phase IIb data to other phase III studies where study designs differ. Before we move on to the open label results, it's worth underscoring how patients actually moved through the study. Not only did we see strong efficacy in the core phase, but participants who stayed engaged and the completion rates were high through both core and open label. Most who were eligible to move into the open label chose to do so. The pattern of completion and rollover speaks to treatment experience that has proven to be practical and manageable from a patient experience standpoint. That acceptability becomes even more meaningful as we look at how patients responded after receiving a second dose in the open label. Here I'd just like to provide another glance at the 2b trial design, specifically focusing on those key details in the open label study. As mentioned before, the open label aimed to assess efficacy and safety of a second 12 milligram dose over a further 8-week period. Results from the next slide of the open label here reinforce the durability and reproducibility of the BPL effect. After patients received a second dose, 12 milligram dose, we see an additional significant drop in the MADRS across all treatment groups. Even in patients who received the 0.3 milligram dose initially, the MADRS reductions were comparable to the antidepressant effect seen in patients who received 8 or 12 initially. More notably, patients who received an active dose of 8 or 12 initially showed a mean reduction in MADRS of 19 points at day 57 of the open label compared to the initial baseline. This data also helped influence our decision to take the 8 milligram forward. Where the 8 milligram looked as good as the 12, giving us a lower dose with similar efficacy, which is always a good thing. Together, the significant MADRS reductions and durable effects tell us that BPL remains efficacious over the long term, with repeat dosing prolonging and deepening the initial improvement. The next slide shows responder rates across the core and open label studies, highlighting how responder rates change after administration of that second 12 milligram dose. On the left-hand side, responder rates during the core study reached the high 20s, low 30% range for the 8 and 12 milligram treatment arms. Importantly, after patients received the second dose, response rates significantly increased across all 3 treatment groups. The 8 milligram dose followed by 12 appears to demonstrate the strongest response, with a response rate of over 80% by the end of the open label extension. The data here supports our dose selection decision for phase III. We'll transition to that in the next section. Similarly, remission rates across the core and open label studies showed a very similar pattern to the one in the last slide. We see a steady rise in remission rates after the first initial dose that increases more noticeably after the second dose was administered. The 8 milligram dose followed by the second 12 milligram dose demonstrates the most efficacious and durable response compared to the other 2 treatment arms. Remission rates reached 67% for the group at the end of the open label extension, which is a substantial increase from what was achieved in the core study. Moving on to the safety and tolerability on this slide. We observed BPL was generally well-tolerated across all doses, with the vast majority of treatment-emergent adverse events being classified as mild or moderate in nature and resolving quickly without intervention. What I'd like to emphasize on this slide is that when looking closely across the doses, the 8 milligram arm showed better safety profile than the 12, although both were very good, with only 1 severe treatment-emergent adverse event drug-related in the core study, the rest being mild to moderate. There were no serious drug-related adverse events reported in the core study and 1 serious drug-related adverse event reported in the open label. The table on the left here lists the most commonly reported drug-related side effects, which were generally as expected. What is encouraging is that most patients were deemed ready for discharge within 2 hours after dosing, which also remains consistent with our expectations and supports the potential for a highly convenient dosing experience in the clinic. The acute effects of 8 milligrams appear to be less intense and better tolerated than 12. It is worth noting that the adjunctive benzodiazepines were available to investigators for agitation, anxiety, but they were never needed, which gives us additional reassurance about the overall containment of the experience. In the context of the comparable efficacy you saw earlier, the balance between effectiveness and tolerability was a key driver behind selecting 8 milligrams as our go-forward dose for phase III. To bring all this data together on the next slide, there are a few takeaways from our phase IIb program. The study is the largest study of mebufotenin conducted and met both primary and secondary endpoints, providing a high level of confidence as we prepare for phase III. Both the 8 and 12 milligram active doses of BPL demonstrated rapid and durable antidepressant effects and resulted in a short psychedelic experience that allowed patients to be discharged after just 2 hours in clinic. Across doses, safety was favorable, with 8 milligrams showing preferable safety profile and comparable efficacy, which is a key driver. The full evidence package so far certainly warrants continued clinical and commercial development of BPL. We're really excited to show you the details of our planned phase III program next. Now let me move on to the next steps of the clinical development for BPL-003, the phase III pivotal program. The pivotal program for TRD is designed to generate the clinical and safety evidence regulators and clinicians expect while informing commercial uptake assumptions. Both single doses and 2-dose induction regimes will be evaluated, and each trial will include a 12-week core study followed by a 52-week open-label extension, supporting assessment of both acute efficacy and long-term maintenance of effect. During the open-label extension, retreatment will be individualized and will occur every 8 to 12 weeks, allowing for flexible maintenance dosing. Efficacy endpoints will be evaluated by remote, independent, blinded raters to reduce the possibility of bias, and study participants will not receive psychotherapy during the study period, which helps isolate the pharmacological effect in this design. The phase III program is broadly supported by several essential factors, including FDA alignment, breakthrough therapy designation, and a robust differentiating characteristics of BPL, such as the short in-clinic sessions, robust efficacy and early onset, and the potential for four to six treatments per year over the long term. Before we get into the phase III fragment, I want to talk a little bit about the name ReConnection, which is what we've named our studies. We've heard from patients that treatment-resistant depression can feel like a disconnection from people, from daily life, and from themselves. The name ReConnection really reflects the core unmet need in TRD, helping patients to reengage in their lives, their relationships, and themselves. That is the outcome we're ultimately aiming to restore with our trials. On the next slide, we show details about the dual phase III program aims to reflect regulatory confidence and generate robust comprehensive data. The BPL-003 trial design reflects both regulatory guidance and real-world stakeholder requirements by incorporating a long-term open-label extension and large participant sample size for safety. These elements are critical for building confidence in key stakeholders around safety, durability, and real-world applicability. Furthermore, by confirming the robust efficacy of an 8 mg dose across 2 independent, well-executed trials, we aim to strengthen our evidence package and reinforce dose selection decisions. The phase III program is designed to support the flexibility and optionality of BPL over the long-term treatment. By evaluating responder patterns and individualizing retreatment timing, these studies will clarify how BPL may be utilized in the real-world maintenance setting. Our overall approach to the dual trial phase III program will broaden our evidence package across safety and efficacy, ensuring clinical adoption and commercial viability at launch. The details here on the next slide depict how each trial plays a complementary role when within the broader phase III program. At a high level, both studies share the same overarching objective: to demonstrate rapid and durable antidepressant effects with a short in-clinic session while also supporting the potential for flexible, individualized retreatment over the long term. ReConnection 1 aims to establish robust efficacy and characterize the dose response. It'll be a 3-arm randomized, double-blind trial evaluating 8 milligrams and 4-milligram doses against placebo using a single dose induction. The 4-milligram dose produces a reliably perceptible psychedelic effect, but with substantially lower intensity and shorter duration than 8 milligrams. This supports its selection as the lower dose control recommended for mitigating functional unblinding while maintaining the potential to detect a dose-response relationship. ReConnection 2 is a 2-arm study comparing 8 milligrams of BPL against placebo using a 2-dose induction. The doses will be administered on day 1 and day 15. In both trials, change from baseline in MADRS total score will be measured at day 29, serving as the primary endpoint. Together, the 2 studies will allow the evaluation of 2 distinct induction regimens and strengthen the potential for flexible real-world treatment tailored to unique patient needs. This slide and the next slide provide detailed designs about the studies. ReConnection 1 is designed to replicate and extend the treatment response that we saw in the phase IIb study and to further characterize the dose-response relationship. Participants in this trial will be randomized 2 to 1 to 2 across 3 treatment arms, 8 milligrams, 4 milligrams and placebo respectively, for a single intranasal administration of BPL or placebo on day 1. 8 milligrams has been prioritized as the optimal dose based on the prior phase I and phase II data, as I outlined earlier. The inclusion of the 4-milligram arm will allow for a better characterization of the dose-response relationship. The primary goal of this study is a strong foundation for labeling discussions and commercial positioning. ReConnection 1, like ReConnection 2, will also include a 52-week open-label extension after the 12-week core part of the study is complete. The open label allows participants to receive individualized treatments with 8 milligrams at 8 to 12-week intervals, subject to predefined criteria. Incorporating a long-term open label extension was strongly supported by FDA feedback and is designed to generate the broader safety database needed for this chronic indication, as well as to understand the maintenance of effect in real-world dosing patterns. Similarly with ReConnection 2, it follows a largely aligned trial design to the first study with a 12-week double-blind core followed by the open label extension. This study will randomize participants 1-to-1 to receive a 2-dose administration of either BPL or placebo on days 1 and 15. ReConnection 1 aims to define the dose response relationship for BPL, the second study will test the clinical potential of a 2-dose induction regimen, exploring the potential to increase the magnitude and durability of the initial response and inform real-world induction optionality. The next slide shows the comparison of both pivotal trials and highlights how the overall phase D program for BPL is structured to support a potential broad flexible label while maintaining and maximizing operational efficiencies. The core design elements across 2 trials, including primary endpoint and study timelines, are intentionally aligned to reduce operational complexity and enable cross-trial data comparison. Together, these programs cover both single-dose and 2-dose induction regimens, along with individualized retreatment during the open label. Now let's look at the future for BPL-003. Minutes from the end of phase II meeting show that the FDA indicated support for and provided constructive feedback on the overall design and the key components of the proposed program, including the overall size of the safety database. In parallel, we're expecting a readout from the phase IIa Part 4 study this year. This is the 8 plus 8 milligram two-dose induction open label study, which will provide additional insights that may inform future clinical and commercial planning. We expect top-line readouts from both phase III trials in early 2029, subject to enrollment and operational variables, which will directly inform launch planning activities and our broader commercial strategy. Looking forward to the next few years, our key milestones reflect a well-planned and sequence timeline, which will position us for continued clinical investigation of BPL and a future approval and launch in TRD. I'm going to hand it over to Ryan, our Chief Legal and Business Officer, to provide an intellectual property overview. Ryan. Thank you, Kevin. Intellectual property is a critical pillar of our overarching business strategy. As you just heard, we're breaking new ground in mental health treatment, it's essential that we protect our innovations to capture their full value. My team's mandate has been to ensure that each of our core programs is safeguarded by a robust patent estate. As we move to the next slide, I'll begin providing a high-level overview of how we're achieving this objective and why it matters, particularly for our lead asset, BPL-003. At the outset, I would note that our intellectual property strategy here at AtaiBeckley is comprehensive. Within this comprehensive strategy, we file patents that cover both composition and method of use claims, we craft those claims in light of and to align with each drug's target product profile, or TPP, as well as its intended labeling. In the simplest of terms, we look to protect what the product is and how it's used. Starting on the left-hand side of the slide, composition claims may seek to protect the drug substance, the molecule itself, including specific salt forms and polymorphs, as well as the drug product, such as the formulation or dosage form. They do so only once these claims have issued, an obvious but key distinction and a point of strength for us here at AtaiBeckley. Notably, these composition claims are indication agnostic, meaning that they cover the compound or formulation regardless of what disease it's used for. As a specific example, here at AtaiBeckley, we've successfully patented the benzoate salt form of 5-methoxy-DMT, also known as meth-mebufotenin, and the inclusion of a key excipient, namely silicon dioxide in our proprietary intranasal powder formulation of BPL-003. In contrast to composition claims, method of use claims, shown on the right-hand side, protect the specific ways the product is used, which can include the indication as an example in treating treatment-resistant depression, dosing regimens, and even the route of administration in some cases. These indication-specific claims are vital in our field, and particularly with respect to naturally occurring or known compounds. For instance, even though 5-methoxy-DMT is a known substance, no one can use our proprietary 5-methoxy-DMT benzoate salt intranasal formulation to treat depression here in the United States without infringing upon our issued U.S. method patents. This dual approach, securing both composition and method claims tailored to the target product profile, is key for effective market exclusivity. This approach also supports our Orange Book strategy, wherein we align our patent claims with the final drug label so that the resulting patents can be listed in the FDA's Orange Book and thus get the full benefit from the Hatch-Waxman Act. This Orange Book strategy ensures that if anyone tries to file a generic, they must contend with our issued patents, giving us the opportunity to legally challenge and potentially block entry of that generic until our Orange Book-listed patents expire. In summary, our comprehensive IP strategy is designed to leave no gaps. We seek to protect the innovative molecule, the precise formulation and device, as well as their use in our target indications. We do so with an eye for ensuring that we get full benefit from the Hatch-Waxman Act. On net, this approach provides a strong foundation for commercialization of the approved therapeutic and multiple layers of defense, making it very difficult for competitors to design around our patents. Moving to the next slide, I'd like to specifically address the patent coverage we secured for BPL-003 here in the United States, since that's our flagship program and our key market. As alluded to in the previous slide, and as we do with all of our programs here at AtaiBeckley, we have pursued a comprehensive IP strategy for BPL-003, including targeting key composition and method claims that are well aligned with and build upon the target product profile for BPL-003. We are very pleased with the results to date, both in terms of the strength of the issued claims and the duration of the issued patents that we've secured for this asset here in the U.S. Diving in with a bit more specificity, we have issued U.S. patents to protect various 5-methoxy-DMT compositions, including BPL-003's drug substance, namely the 5-methoxy-DMT benzoate salt, as well as other potential salt forms and polymorphs of 5-methoxy-DMT. These patents currently have a lifetime out to 2041. Changing the focus to drug product claims, we also have issued U.S. patents on BPL-003's formulation as well as its route of administration. As discussed previously, one issued U.S. patent covers the proprietary intranasal dry powder formulation of 5-methoxy-DMT combined with silicon dioxide as an excipient. This issued drug product patent provides us with Orange Book listable patent protection on BPL-003 to August of 2043, providing AtaiBeckley with an enviable period of potential market exclusivity. Cover future possibilities and consistent with our comprehensive IP strategy, I should also note that we've secured issued U.S. patents protecting alternative routes of administering 5-methoxy-DMT, such as sublingual and buccal. Finally, with specific focus on method claims, we have secured issued method of use patents here in the United States for treating depression with 5-methoxy-DMT, which similarly last into 2041. Obviously, this slide is focused squarely on the issued patents we have achieved here in the United States. Our mission to transform patient outcomes by developing rapid-acting, durable, and convenient mental health treatments extends beyond the U.S., and our global IP estate reflects these broader aspirations with strategic filings in major markets globally, including Europe, United Kingdom, Canada, Asia, and more. We have achieved patent grants in some of these markets, for example, in Europe and the United Kingdom, whereas others are in process. Where we secure patents abroad, we anticipate global patent protection timelines comparable to United States. Where does that put us? To put it plainly, BPL-003 is very well protected, particularly here in the U.S., pursuant to a comprehensive IP strategy that provides for exclusivity potentially through the mid 2040s with patent term extensions. This strategy also allows us to deter generic challengers by listing these patents in the Orange Book at such time as BPL-003 is approved. Taken together, we believe that our IP strategy and our success to date in executing on that strategy significantly de-risk the commercial potential of BPL-003, giving us confidence that if we reach the market, we can operate without generic competition for many years, allowing us to invest fully in the product's success now. With this backdrop, I will now turn over to my colleague, Kavita, who will discuss the BPL-003 commercial framework. Kavita? Thank you so much, Ryan. I'm really excited to be here. Kavita Pankey, Senior Vice President of New Product, Planning and Commercial. As Ryan said, I'll talk about the commercial vision and even our early go-to-market plan for BPL-003. Let's take a look at the landscape we're operating in. Treatment-resistant depression, as we've heard, affects a huge number of people, and yet the market remains largely untapped. The STAR*D trial showed that 1 in 3 individuals with major depressive disorder do not respond to 2 or more oral antidepressants. That's millions of people, $3 million-$4 million adults in the U.S., if not more, who are left without effective options. There has been progress. Spravato has made meaningful inroads. Even so, it has reached less than 3% of those who qualify for TRD treatment, which means over 95% of people with TRD are still not receiving an FDA-approved therapy. Why is that? You know, when you look at the patient experience, it's really not surprising. People need treatments that work quickly, that last, and that don't require them to reorganize their lives to take these treatments. You know, frequent clinic visits where they can't drive, must arrange support, and lose hours of their day create significant barriers that many just simply can't overcome. The burden of accessing care has actually become part of the disease burden itself. There is a real paradigm shift underway in psychiatry, and one that moves us from simply managing symptoms to actually enabling durable, meaningful change. I've actually worked in this space for a pretty long time, and what we're seeing now, it feels different. It actually feels transformational. We look on the left side of the slide today. Our tools are chronic antidepressants. They do help. They help many people. They come with real limitations. Slow onset, often taking weeks or months before we know whether they'll even work. Chronic side effects, and some of the most problematic, like weight gain, sexual dysfunction, sleepiness, that drive people off the treatment. The burden of daily dosing, or in the case of Esketamine Spravato, frequent clinic visits that still require ongoing chronic administration. You know, ultimately, these treatments manage symptoms rather than creating lasting or root-level change. Patients remain stuck in a cycle of maintenance and managing symptoms. The vision for tomorrow looks very different. Psychedelic-based interventional psychiatry offers the potential for rapid efficacy. You could know within a day or two whether it's working for you. It offers the possibility of durable benefit paired with intermittent rather than chronic dosing. It opens the door to neuroplastic change addressing underlying biology rather than just the symptoms. You know, the future we're moving toward is one defined by rapid results, durable efficacy, infrequent dosing, and the potential for lasting change. Why BPL? You heard from Srini, from Kevin's deep dive into the data. The story is actually very simple. BPL-003 has the potential to deliver what I call a trifecta that TRD patients have been asking for. Works fast, is durable, and it's convenient together in one treatment. Here's what the data shows so far. Rapid improvement with a single dose showing effect by day two. Durable benefit with a 6.2-point placebo-adjusted MADRS reduction at week 4. This effect was sustained for 16 weeks in the open-label study for most patients. True convenience, requiring a handful of treatments over the course of the year in 2-hour clinic visits. This matters because it expands who can realistically access this care. People with demanding jobs, family responsibilities, or long distances to travel. People who have been effectively shut out of current treatment-resistant depression treatments may finally have an option that works for them. A trifecta of improvement. When we look at BPL against the competitive set, so the current standard of care as well as pipeline opportunities, it has a credible path to be best-in-class positioning because it is the only asset in the category that aligns with the 3 attributes that consistently drive adoption and reimbursement. Rapid acting, durable, and convenient. Of course, importantly, while we cannot make direct comparisons without head-to-head data, the landscape makes the differentiation quite clear. Oral standard of care, as I mentioned before, often slow onset, many don't respond to the drugs. Chronic daily use limit both effectiveness and adherence for patients. Esketamine Spravato. Very meaningful innovation, but durability remains a challenge for many. We hear this quite a bit from clinicians who use the product as well as from patients. Roughly half of patients require biweekly or even weekly maintenance dosing, creating ongoing cost and operational burden. The long-acting psychedelic pipeline programs, multi-hour in-clinic dosing sessions can introduce staffing, throughput, and scalability real constraints that will slow adoption and limit reach. Why is BPL positioned to lead in the space? It's the only program that aligns across all three high-value attributes. Rapid, early onset of effect. Durable, sustained benefit without chronic maintenance. Convenience. A small handful number of short two-hour sessions rather than multi-hour or weekly commitments. The implication is straightforward. A treatment that delivers speed, durability, and low operational burden expands the addressable TRD population and reduces friction across patients, providers, and payers. You know, this combination is rare in psychiatry, and it's why we believe BPL has the potential to truly reshape the paradigm. Let's double-click into the current standard of care for TRD, Spravato, and the durability of effect in the induction phase. Keep in mind, once again, this is for illustrative purposes only and no head-to-head studies have been conducted. What this graph attempts to do is it juxtaposes Spravato's primary efficacy data, a change in MADRS total score from baseline, from their monotherapy trial against the BPL-003 phase IIb 8 mg data. What you see here is a comparable MADRS response curve, which took Spravato 8 dosing sessions versus a single dose for BPL. Think about that. Compound that annually, that's a lot of time in clinic dosing sessions and healthcare utilization that is potentially saved with BPL-003. What we can directionally conclude here is that Spravato takes 8 doses to achieve a similar efficacy result that BPL can potentially achieve in a single dose. Now let's shift and look at the maintenance therapy component. Based on an analysis of real-world Spravato data, we know that about 70% of patients are being maintained on at least one dosing session per week, and the majority of patients are on the higher dose, 84 milligram dose by treatment session 6. What you see on the left is the annual, the assumed annual cost of Spravato, and this is WAC-based pricing. What this translates to, if you put together the actual real-world utilization compared to the WAC prices, the real-world cost is on the upper end of the $60,000-$65,000 range. When we think about BPL, of course, it's early to provide any pricing guidance at this time. However, Spravato is the best price anchor we have today. If we deliver on our trifecta of value, similar or better efficacy with a single dose, rapid effect, and convenient 2-hour dosing model, we believe there could be opportunity for premium pricing. Our goal is to build a treatment model that puts patient safety and convenience at the center without requiring in-session psychotherapy, and that can be deployed within today's interventional psychiatry infrastructure. What I'm describing and what you see on the slide is not our clinical trial protocol, but it's our vision for real-world implementation, with the specifics that'll ultimately be guided by the data we produce. This model mirrors familiar in-clinic workflows used across other therapeutic areas, making it straightforward for sites to adopt and scale. Let me just break this down. There's the preparation session, where patients meet with their provider for education, expectations, questions, standardizing readiness, and reducing variability. There's the dosing day. Patients come in, they check in, they move to a private room and receive the nasal spray dose from their provider. A trained healthcare professional remains with the patient throughout their experience. There's efficient discharge. We anticipate a roughly two-hour post-dose observation window, similar to Spravato, enabling predictable scheduling and higher clinic throughput. Importantly, a follow-up visit conducted either in person or remotely, ensuring continuity without adding burden to the patient. I wanna underscore, no psychotherapy requirement. There's no need for specialized therapists, dramatically reduces costs, staffing constraints, and operational complexity. To summarize, our vision is a model that is simple, familiar, and resource-efficient, lowers barriers for providers, expands the number of clinics that can participate, and increases patient access, especially in markets where staffing, space, and reimbursement are real constraints. BPL-003's short in-clinic model creates a fundamentally stronger economic and operational profile for patients, providers, and the healthcare system. In an 8-hour clinic day, a 2-hour dosing window allows a provider to treat 3 patients per room compared with 1 in a, let's say, 6-hour long session psychedelic model. Observation revenue is effectively the same, right? 6 total hours per room. The real economic difference comes from the drug revenue. In a buy and bill environment, the margin on drug administration far exceeds the margin on observation time. In fact, observation alone often doesn't cover the incremental staffing and monitoring costs. The takeaway is, without meaningful drug revenue, interventional psychiatry simply may not be sustainable for many clinics. The equation becomes straightforward. More patients dosed, more drug administered, more clinic revenue. A shorter session directly increases throughput and makes the model economically viable. I want to address three key advantages and real-world examples of a short in-clinic model. First, higher throughput and greater access. Clinics can treat more patients per day, opening the door to serving that 95% of TRD patients who currently aren't receiving an FDA-approved treatment and giving clinics more flexibility in scheduling. Real-world practicality for patients. Let's think about this. A full day in-clinic model is unrealistic for most people. Life happens. There's work, there's childcare, there's transportation, there's delays. If a clinic books one patient per room per day and that patient is late or needs extra time, the entire day collapses. A two-hour model can really avoid this fragility. Reduced provider burden and burnout. Expecting a provider to remain engaged for six to eight hours straight may not be feasible. Breaks, turnover, and fatigue are real constraints. Actually, caregiver burnout is already a growing issue in psychedelic monitoring. Shorter sessions dramatically reduce that strain. Across economics, operations, and patient experience, a short in-clinic model is simply more scalable. It supports stronger clinic economics, increases patient throughput, and lowers the burden on staff, which I think are key ingredients for broad adoption. Next slide. BPL-003 supports a lean, highly targeted commercial model because the TRD interventional psychiatry market is already very concentrated and built on existing infrastructure. The treatment fits directly into current workflows, making it a true plug-and-play offering. There's a concentrated prescriber base. Of the 6,000-7,000 REMS-certified Spravato sites today, our data suggests that about 10% account for the majority of prescription volume, about 75% of the total volume. Taken together, a really focused field force, under 100 representatives can cover the highest value centers that already understand interventional psychiatry, did the hard work of, you know, organizing their clinics, and are comfortable with similar models of care. I want to talk about operational fit. These clinics can run Spravato and BPL side by side, potentially using the same room, staff, and processes. That level of operational overlap is just not possible with long in-clinic psychedelic therapies that require dedicated rooms and multi-hour sessions. In market readiness, we are actively building as we speak the ecosystem with clinical leaders, high volume practices, payers, and patient advocacy groups to ensure early seamless adoption at launch. This combination of concentrated demand, operational compatibility, and ecosystem engagement positions BPL for efficient, scalable commercialization. I want to conclude here. We are laser-focused and invested in treatment-resistant depression. TRD is just the beginning for BPL. Beyond that, we are strategically exploring adjacent psychiatric disease areas that have scientific rationale, high unmet need, and strong commercial potential. As Srini mentioned in the onset, we also have a portfolio of exciting candidates to support optionality and broad impact in mental health. With that, we will take a short break, we'll come back, and I am super thrilled to introduce and to be able to participate in our next session, which we've brought a set of panelists, experts, key opinion leaders in the field, Doctors Feifel, Wilkinson, and Dr. Hendricks, who will have a chance to introduce themselves and their practice. We'll talk about and share real-life perspectives on treatment-resistant depression, interventional psychiatry and the true potential and adoption of these new class of therapeutics. Thank you so much. With that, I think we are going to a short break. Hi, everyone. I think we're back from that short break, and you know, I may be unbiased, but I think this is going to be a really great part of the meeting and a great conversation. As I mentioned before we went for break, but I'll reiterate, we are very excited to have three psychiatry key opinion leaders in the U.S. join us this morning for this session. In a moment, I'll let them introduce themselves. But, you know, the goal is really to really understand real-world treatment patterns, how we think about the treatment landscape, and the pipeline potential, and just real-world experiences on managing these patients. With that, we have Dr. Feifel, Dr. Wilkinson, and Dr. Hendricks joining us. Maybe I will start with Dr. Wilkinson. If you can just introduce yourself, where you practice, and talk a little bit about your, you know, your practice and the patients you see, and yeah, and anything you wanna share in your intro. Sounds great. Thanks for having me here, Kavita. My name is Sam Wilkinson. I'm Associate Professor of Psychiatry at Yale. I'm the Medical Director of the Yale Depression Research Program. I help run a combined research and clinical entity. The clinical service is a pretty busy interventional service. We do a lot of ECT, a lot of Ketamine and or Spravato, and a growing number of TMS treatments. In a given week, I think we have about 80 slots for either Ketamine or Spravato, so those two and a half hour slots. Yeah, that's a little bit about me. I'm grateful to be here. Sounds great. Thank you. Welcome. Dr. Hendricks, why don't you go next? Remember to unmute myself. Hi. I'm Peter Hendricks. I'm a clinical psychologist, university professor, and endowed chair in the Department of Psychiatry and Behavioral Neurobiology here at UAB. My work centers on psychedelic approaches for mental health conditions. I've done that now for about 10 years, which is hard to believe. I focus on depression, substance use disorders, and related challenges. I have a practice here at UAB and also collaborate on clinical trials, provide consultation in academic and research settings. You know, I'll just say briefly, the TRD patients I encounter or study typically have failed multiple antidepressant trials, II, III, IV or more. They present with moderate to severe symptoms and span a broad demographic, working age adults, often with comorbidities. In our region, we see a mix of insurance types, commercial, Medicare, Medicaid, and uninsured or self-pay, which influences access to interventional options. Great. Thank you so much. Thanks for being here. Dr. Feifel. Hi. Thank you for having me. I'm a board-certified psychiatrist and a professor emeritus at University of California, San Diego. I'm also the founder and CEO of an interventional clinic called Kadima Neuropsychiatry Institute. I was a very early and enthusiastic adapter of interventional psychiatry, I think before it was before we described it as such. I started actually the first, the very first Ketamine clinic outside of research back at UCSD in 2008, and started doing TMS around that same time when it was FDA approved. I was very eager to move into, you know, different types of treatments than had been sort of dominating psychiatry for the previous half century. In 2017, I gave up my tenured position to open up Kadima, and we do probably also about 80 treatments a week of either IV, IM Ketamine and Spravato intermixed in sort of same treatment rooms. We do a very robust TMS program and very large number of clinical trials, mainly with psychedelics. Thank you. Maybe we'll start off with, you know, there was quite a bit in the session before about, you know, TRD sort of representing a large population of patients, yet this practical factors, convenience factors, things like that make it sometimes difficult for these patients to access more of the interventional treatments. I'm wondering if you guys can comment a little bit more about that. You know, are there practical considerations that influence maybe what type of treatment you try next for these patients, or if they are going to be able to adhere and stay on these treatments? If someone wanted to comment on that, or I can pick on someone, but I'm sure there's a lot to say. I can speak to this briefly. Yeah. I'll start off. You know, we really started expanding our Ketamine service prior to Spravato FDA approval, probably around 2015, 2016. This was in line with a very busy existing ECT service. Mm-hmm. You know, some of the executives, we had to convince them that, look, you know, we're not gonna, you know, rob Peter to pay Paul. That was not at all what happened. Our ECT service has not suffered. I think that speaks to the principle that there are just a lot of people, and clearly ECT is one thing. There's a lot of people with TRD who are not getting treatment with ECT, which, you know, prior to Spravato and Ketamine was one of the only things for TRD. You know, the, a lot of this is related to the clinical profile and the side effect profile of ECT, but also the, you know, the inconvenience of not being able to drive and so forth. You, you have that a lot with Spravato, but it speaks to the principle there's a number of patients out there that are not getting interventional treatments, and I think in part related to these factors of convenience, and so forth. Right. Anybody else want to comment on that? Yeah. You know, I, people often ask me, you know, including patients, you know, what, how do you decide, you know, which intervention, TMS, Spravato, IV Ketamine, and, you know, the answer is that often it's driven by the practicalities of each of those. Mm-hmm you know, first of all, you know, Ketamine is not covered by insurance, so there's a practicality of finances, driving, you know, that treatment option. You know, between TMS and Spravato, they have different logistical requirements, you know, both of which represent inconvenience to patients, but, you know, it depends on which fits better. You know, one requires, you know, daily short treatments for a long period of time, you know, six to nine weeks. And they can drive each way. You know, the Spravato is less frequent, but frequent twice a week for a month and once a week for a month and as needed each time, longer sessions, 2 to 2 and a half hours typically, and they can't drive. You know, somebody is, you know, it really depends. At sometimes it's really just one is a non-starter for whatever reason. It is much as we wouldn't like it to be, we'd like it really to be driven by, you know, precise, personalized clinical decisions. It's often just a matter of pragmatics. Yeah. I'll just add to that. Yeah. Trying not to be redundant, but to give some sense of the scope of the issue here, just in Birmingham, Alabama, which is a relatively small city, the metro area is maybe 1 million. UAB likely has 15,000 patients with depression, and 30%-50% of those are TRD patients who cycle through several oral medication trials, sometimes for years, before interventional therapies enter the conversation. As noted, this delay stems from stepwise guidelines, insurance requirements, patient-provider hesitation around options that are viewed as invasive or require a fair amount of monitoring or travel, as noted. You know, I'll be honest, I'm excited about this new option on the table, potential new option on the table, especially if it can facilitate conversations around earlier intervention when this rapid symptom relief could be critical to prevent functional decline, hospitalization, suicidality. I just don't think I'm gonna overstate the burden of prolonged inadequate response. It's just, it's substantial. I think tools like Ketamine, Esketamine, and TMS are helpful for some. They've been shown to interrupt the cycle for some, but I'm personally not satisfied with the response and think we need something better. Not only something better, but something that occurs earlier could really improve outcomes and quality of life. Yeah. That's great. Thank you. To that, to this conversation, in your opinion, you know, what are the key unmet needs? Like, there's been a lot of innovation, right, in the space in general, in depression, MDD. There's a lot of options in your toolbox. What are... You know, we highlighted some earlier, but in your opinion, in your practice, I want to hear, you know, what are kind of the key unmet needs, especially for these refractory patients? I always tell people in this space that there are kind of three factors. 1 is overall efficacy, the other is speed, and the other is side effects. If you're trying to develop a new therapy and it doesn't get at least 1 of those, then you're not really gonna add value to what is in existence. Going back to this theme of convenience, with these novel interventional/psychedelic treatments, I really do think some of the two issues, again, assuming that they all have pretty good efficacy, which is mostly seeming to be the case. Mm-hmm maybe some questions about that. The two factors, and I think you've already brought this up, are, you know, how long is the monitoring and how frequent do patients have to be dosed? That will just determine so much of the logistics, so much of how, you know, how clinics are able to adopt this. You know what, as you pointed out here, and we recently learned from the, there was a large analysis of the Spravato REMS data that so many of these patients are coming in weekly as the most common frequency of treatment. You know, a lot of the clinics just fill up, right? They don't have openings for new patients if they're treating all their patients weekly or so many of their patients weekly. That's another aspect. I mean, you know, Spravato, it was slow in the beginning for the first couple of years, and it really has taken off as people learn how to adopt and implement this. Clinics just fill up in part because the most, one of the most, really the most common dosing frequency is weekly. Again, the three clinical factors, enhanced efficacy, rapid onset, and improvement in side effects, the two logistical factors, how long are these interventional treatment is gonna take for observation, how frequent do you have to redose? Much hangs on those factors. Yeah. Thank you. I would definitely agree with Dr. Wilkinson about those three factors. I mean, those are the big three. Just to elaborate a little bit on them, right now, you know, with the relative innovations we've had, you know, in the last decade or two with TMS and Ketamine, they really represent sort of somewhat of a of not overlapping, very stark contrasts, you know, that sometimes is a dilemma for patients. You know, Spravato can work fast. Right. Not as fast as the drug it was inspired by, Ketamine. You know, it's not durable. You know, just to get it going, you need to come in 12 times over 2 months. As Dr. Wilkinson mentioned, most people need to come in for maintenance on a frequent basis, not uncommonly once a week. I actually had spoke to a patient yesterday that wanted to talk to me because she had done amazing with Spravato until, you know, she was forced to go to once a week because, you know, that's the label. She's now on maintenance for once a week. Its insurance won't cover more than once a week. The durability is not very good. On the other side, the TMS is not fast, although the durability is better. Then you have patients who are in extremists. They're really in a difficult situation. They need fast relief. Right now we have these two treatments and you gotta choose speed or durability. To be able to combine both is, would really, really be, sort of, an advance in the field. I just want to make two other quick comments. Yeah. I mean, Dr. Wilkinson mentioned side effects, and you know, I don't think that was really emphasized sort of in the presentation that when you're taking a drug every day, you know, you're a prisoner to the, you know, the chronic presence of the drug, sorry, of the drug, in your body and those side effects. When you're taking a drug once periodically, maybe, you know, every quarter or so, and then no drug is in your system, I mean, that is a tremendous paradigm shift in the ability to kind of, you know, not suffer from those side effects. The last point I want to make is we talk about efficacy improvements, and we always think about this thing called TRD, which has a very specific definition of, you know, failing 2 antidepressants. You know? Ask most patients who don't meet that criteria who will say. Failing is usually, you know, not being, not having your depressive symptoms reduced by more than 50%. So if you have a 55% improvement in your reduction in your symptoms, you're not treatment resistant. Ask those patients who aren't treatment resistant because they do get more than a 50% improvement, whether they are satisfied with their antidepressants. They'll say, "No, I still suffer a lot of, you know, symptoms, although it's better." "No, the cost I pay is, side effects like numbing or libido." We talk about this group of a third of patients on medications who are TRD. I think almost 100% of patients who are on conventional medications would be interested in something that allows them a more complete symptom reduction and freedom from the side effects acquired produced by taking daily dosing. Yeah. Yeah. I would agree wholeheartedly with that. I think most patients on SSRIs or SNRIs would say they feel a little better, not much, and there are a list of unpleasant side effects, often weight gain and sexual dysfunction, which are very unpleasant, sort of at the top of the list of side effects you'd rather not have. I also wanted to mention that, you know, many of the patients that we see are socioeconomically disadvantaged. Any intervention that requires frequent visits- Yeah can be a significant burden and can, I think, add to this sense of demoralization that nothing is quite working and what's suggested next is a rather significant investment of time and energy. As noted, the response is just not adequate for many, and the durability is variable. There's clearly something that we need that can respond to the sort of demanding and sometimes chaotic lives that many people lead, something that can be, as noted, not only durable, but rapid, and that can be done in an efficient way. Great. Thank you. With that, I do want to segue into the tomorrow, let's say, right? The new potential interventions, the therapeutics, the psychedelics that are emerging. Can you talk a little bit about, you know, just your thoughts around that, how you see, you know, these playing together in the real world? You know, what are the, what are sort of the, your practical kind of, thoughts around those long versus short in-clinic times? I don't know if we have an established order. I could break the model here and go first. Let's do it. Yeah. I think this is a really interesting question. I mean, the truth is we just don't know if the length of the experience is tied to more durable or more robust response. I think an argument could likely be made based on a limited number of animal studies or basic science studies. We just don't know. I think at the moment, I would argue at least that, for me to use a much longer acting psychedelic, let's say, there's got to be a really good argument for that because it's otherwise as noted, very inconvenient for the patients, very resource intensive, and is just going to limit scalability substantially. I think that shorter acting compounds just have a tremendous advantage in that they work well with clinic workflow. It's unknown. I think, you know, BPL-003 here is really unique because the mechanism of action might in fact be unique not only in that it's shorter acting, but the mechanism of action at the brain level might be different than other psychedelics as well that could give it a substantial advantage. Right now, I'm not sold on the idea that a longer experience is in any way more beneficial, but we'll have to see. At the moment, a shorter acting experience is far more practical. Anyone else have thoughts on that? I would say that, you know, I absolutely agree with Dr. Hendricks, and I was. You know, I would not have predicted this. I would have if you had asked me at the beginning of this, you know, this, the revolution we are in studying psychedelics, you know, is a longer trip gonna produce better results? I would say yes. If nothing else, just sort of a longer exposure of the, you know, of the brain to this. The results are proving my prediction wrong. It's really interesting. It's the beauty. That's beautiful about science is, you know, it teaches us things. That's great. That's great because, obviously it's self-evident that, shorter subjective experiences or quicker recovery time is an advantage. It, you know, it may mean that the duration at least is not important, or it may mean, as Dr. Hendricks pointed out, that BPL-003 has some advantageous mechanisms that actually allow it to produce comparable efficacy to some of the longer agents that we've seen in studies without that longer experience. Yeah. I think also from a clinic consideration, there's the economics of this, right? If you, if you have an eight-hour observation period, there's going to have to be a pretty substantial reimbursement for the clinics to want to implement these. Even aside from that, the logistics of dedicating, you know, 2 staff to 1 patient. The economic considerations for long versus short acting are quite disparate. Yeah. To that point, Dr. Wilkinson, you know, do you see, like a BPL, you know, sort of slotting assuming that it sort of has that two-hour dosing paradigm, the already established Spravato sites, could this sort of be a slot into that infrastructure, kind of a plug-in sort of thing? We talked about that in the presentation, but just wanted to get any of your thoughts in terms of how that kind of infrastructure and kind of economic piece sort of would fit in. I would say very likely yes. I alluded to this earlier, but it took a long time for Spravato. Yep ... to get, you know, taken up into practice, I think, because practitioners had to change their infrastructure, the way they approach this, the, you know, the buy and bill modeling as well. It's not something they were used to. You know, there was a lot of kind of weed whacking going on to kind of forge that path. There's inevitably going to be some- Yeah ... with an agent like this. You know, assuming it is it's going to be much easier because that path is there than if you had to start it from, you know, just the jungle, so to speak. Yeah. Yeah. Anyone else have thoughts on that topic? All right. I want to shift gears and maybe talk about BPL. I mean, that was of course the focus of the presentation, and Kevin and Srini provided some of the clinical information around that program. I know a couple of folks, I think David, Peter, you guys have experience with the product from a clinical trial perspective. Would love to sort of get your thoughts from what we heard, from what we saw this morning and, you know, with your experience. What do you think about the data? What aspects do you think are particularly meaningful, interesting, maybe differentiating from what you've got today in your toolbox? Well, I'll jump in. I'm really stoked about the data. you know, I mean, the efficacy was so great. you know, so, you know, it hit all, hits all the, all the marks. you know, rapid onset, durable. I mean, the study was eight weeks, and I think, you know, Srini pointed out that, you know, at eight weeks, it was holding steady. you know, we maybe seeing only a slight decrement, and whether that was a trend or not. We really don't know how long, a single dose lasts, but we know it lasts at least eight weeks, and it wasn't looking like it was about to poop out, quickly. The other... What also was interesting, was that I don't really recall any other study where the peak effect wasn't at 24 hours. An interesting phenomena with BPL-003 was that the subsequent time points showed even a greater separation from placebo, especially with the 8 milligrams. This is something, again, may go back to the somewhat unique pharmacological mechanism, but usually when we think of psychedelics is like, you know, they blossom right off the bat, and then it's a slow wilting over time. BPL actually grew for the first couple of measurement points and then kind of started to hold steady. I just Who knows how long it's gonna... It's, that's super cool and it's everything you would want if you were to put in an order for a drug to treat depression. Yeah. I'll add to that too. I would first say, since I'm a scientist first and foremost, I try to always maintain a very skeptical view, and am influenced by a famous philosopher, Karl Popper, who would say, "You really need to bend over backwards to prove yourself wrong. If you fail to do so, then perhaps you've had a success." As I would be with any clinical trial, I was skeptical, and really pleasantly surprised at the results for a number of reasons. As we noted, the rather rapid, the rather robust and durable effects were really wonderful to see, but also the safety profile was fantastic. You know, I say that in part because there's always going to be in the psychedelic world some degree of use that occurs outside of controlled medical settings, naturalistic use. It's unclear what's happening in those contexts. Now I'd like to say that the difference here would be akin to having a cavity filled in a dentist office versus having a cavity filled by me in my basement. I mean, these are completely different things. You wouldn't want me filling your cavity, and I think the things that happen naturalistically can sometimes scare me. I think again, these are completely different things, and the sort of concerns I may have had from the kind of unusual things that you see in the wild did not at all generalize to this clinical trial, which was, you know, rigorous and objective. Despite my most skeptical view, I think we had data that really pleasantly surprised me. Like David, I feel really quite enthusiastic and excited now. That's great. When we think about patient types, patient characteristics within treatment-resistant depression, any, you know, characteristics or subpopulations come to mind that you think or maybe that you've seen in the clinical trials that can potentially maybe benefit from short-acting or BPL or that kind of thing? Like anything that sort of comes to mind at all. Well, I'll just jump in really quickly 'cause I have a thought. I mean, the first is all potentially. I don't see any who wouldn't be considered. The one thing that jumps to mind, since so much of my work is with lower income patient populations, that this could be especially beneficial given the time demands are significantly reduced. Yeah. Any other thoughts on that one? I just say, you know, to follow up on that, you know, a two-hour treatment is feasible without having to give up a day of work, right? I mean, we have a lot of patients who do Spravato, but they, you know, they just, you know, they couldn't give up their work. They'll come, you know, at one of our later appointment times, you know, 4:00 P.M., 5:00 P.M. They get in a full day of work for the most part, and then they do that. With some of the longer ones, that's just not possible. I mean, you know, you're calling out for the full day if you need to be in the clinic for six to eight hours. One of the things I think, David, when you and I had chatted about a little bit is even in this, the clinic, sort of the staff burnout and the need for maybe additional staff or longer hours for the staff based on longer sessions. Any thoughts? I feel like that theme is sort of coming up more and more, right? Even just the caregiver burnout and that type of thing for such long hours. Any thoughts or comments on that issue? You know, right now, the requirements in the clinical trials are that the facilitators are licensed therapists. You know, I assume that's probably gonna be the requirements when at least initially when these drugs are approved. You know, that you have to think about that for a for a licensed therapist, that's a full day of clients that it's an opportunity cost. That's a big opportunity cost. If you have, like we contract our facilitators. You know, I don't think a lot of them are willing to do it on a regular basis, like multiple times a week because they wouldn't be able to have a practice, right? They have to be there for their patients, right? A two-hour intervention or even doing two of those, you know, and still having half a day is much more practical to work into their, you know, professional careers. Kavita, I'll say also, I think I have now personally administered psilocybin to close to 100 participants, and was the lead therapist for many of these sessions, and they're demanding, they're long, and they can also be characterized by, like, moments of significant anxiety on the part of participants, and it would not be unusual for someone to ask to leave. That's always anxiety-provoking for the therapist. We certainly don't want anyone eloping the room, especially when their consciousness has been altered. But those sessions are challenging. You know, obviously I think there could be a place for psilocybin as well- Sure 5-MeO-DMT is not just shorter-acting psilocybin. I think it's unique in many different ways, and it might be especially appropriate for certain mental health conditions like TRD. I will say as someone who has administered psilocybin and been a part of these sessions, 5-MeO-DMT was a refreshing change, less demanding on us all, and I have to say, like, in some ways quite gratifying because to the degree that it was appropriate for me to observe this in some of these trials, I saw with my own eyes participants who appeared to be depressed in every way at 8:00 A.M., and by 9:00 or 10:00, I saw a different person in front of me, someone who's animated, smiling, and talking, and just remarkable to see, like almost to the point, as I mentioned, as a skeptic, you can't believe what you're seeing. Thank you. That's actually a really good point. You can, you know, you know, being a investigator and, you know, being responsible for, you know, assessing patients before they're leaving the clinic, you do really see a difference at the end of these sessions. I mean, you know, patients are drained at the end of the long, I mean, you know, they've been in this room, the experience has been much longer, and they're really emotionally drained. I mean, even if they have a great, you know, it was a positive experience, and they'll have a therapeutic effect, it's depleting to be to have a, you know, 4, 6, 8-hour subjective experience and also be in the same room. Very different with BPL. It's almost like, you know, it's almost like you know, come in for a visit, you do it, and, you know, leave much more akin to our Ketamine treatments where people are actually, you know, up, just more energetic when they leave because it wasn't such a draining logistical experience and subjective experience. Dr. Feifel, could I just follow up? When you know, the Ketamine, the Esketamine rooms that you have, do you see using those same rooms potentially for a product like BPL? Would there have to be some changes or things like that? Of course, it's a matter of the data and what we see in the ultimate REMS program. Just curious on your thoughts around that. Absolutely. In fact, you know, we have rooms that are differently configured and larger for, you know, our clinical trial subjects because, you know, for the most part, those are longer sessions. You know, in the Ketamine rooms, you know, we have just, you know, patients are sitting in a chair, a nice, you know, comfortable reclining chair. Whereas if you're gonna be around for 8 hours, you need to have, you know, a bed option, you know, a chair option. You know, you're having a facilitator present, who also, you know, you can't just stay in one place. We've, you know, we have rooms that were designed with the idea of these longer treatments. Had they been two hours, they fit in perfectly with our Ketamine treatments, our Spravato treatments. We could use those rooms. Great. Oh, Peter, I think you're on mute. Sorry about that. I just wanted to add, too, and, you know, this is coming from a place of, like, excitement, obviously, and optimism. Even when we're conducting studies with psilocybin to administer, you know, two or even three doses in a week would be pretty demanding on everybody. My first thought after being a part of this phase II trial with Beckley was we could, in the clinic, administer several of these administrations in a day. It's not just a matter of sort of practicality, but also just it's sort of a psychological effect for the interventionists. I think that would also be easier for them to do. Just had another practical thing that isn't obvious unless you're sort of, you know, been doing these kinds of things. You know, cancellations happen. You know, we typically do 15 Ketamine/Spravato treatments a day with multiple, you know, rooms being used concurrently. You know, cancellations happen and, you know, that's a, it's a two-hour slot. You know, if you have a long treatment and a patient cancels for whatever reason, you know, it's not something you can fill, you know, quickly 'cause. Yeah ... requires people to have a, you know, like prepare for taking a whole day off. That's a huge economic loss, right? If a cancellation. Also, we with the two-hour, the two-hour session, you can on fairly short notice fill that slot because, you know, patients can say, "Okay, I can come at this afternoon for," whereas that would not work, you know, if the whole session is six or eight hours. Yeah. That is a fantastic point. Well, this has been great. I'm gonna wrap with a question that I think we've all sort of got to in some ways, you know, how do you see in this future state, there are a number of innovations and options, hopefully that are coming to market, you know, patients definitely need new options. Well, how do you see BPL kind of fitting in? What's the positioning? Are there, you know, that broad patient base of TRD that are not currently still maybe cycling through oral antidepressants, is that an opportunity? What is sort of the, you know, where do you see this kind of fitting into your treatment armamentarium? Maybe I will pick on Dr. Wilkinson to share some thoughts on that. Yeah. I think it'll be a question of, so taking out economic consideration, really what I mean is third-party considerations. Yeah and coverage and prior auth. Yeah. Taking that out, I think it's a question of, where does it fit with respect to Ketamine and or Spravato? Certainly if the data from phase II hold out for phase III, it's a lot more convenient. Initially there's gonna be some hesitation with providers because it's a new thing, right? Sure. It's, I could envision a, you know, where it goes first for a lot of patients, again, in part because of those very practical considerations and if things unfold the way phase II would indicate, you know, much less of a burden on time and so forth. There probably are gonna be patients who, again, sort of, come out of the woodwork, so to speak. Like I started this with talking about how when we started, you know, launched a fairly large clinic in Spravato/Ketamine, it did not eat into our ECT patients because there was a number of patients just not willing to get ECT but were still struggling. I think that's probably gonna be a similar thing, right? I mean, the TRD population is anywhere from, you know, 1.5 million-7 million people in America, depending on how you define it. I think there's about 60,000 people who have had Spravato. There's a huge portion who have not, for whatever reason, because of distance, because of accessibility, or because they're like, "I just can't do twice a week for 4 weeks, and then once a week," and so forth. It's not always a necessarily competing, but a... you know, those patients will so to speak come out of the woodwork and say, "Yeah, I can potentially do this treatment. Yeah. It does remain to be seen, I think, where it falls in line in the sort of treatment algorithm with respect to Ketamine and or Spravato. But I could definitely see it coming first because of practical considerations alone. Thank you. I'm gonna do a final roll call. David, any thoughts on that? I think Dr. Wilkinson really articulated it really well. I mean, you know, I think that, I'm not one of those people who think that we're gonna find great differences in different psychedelic agents across different indications. I think there's gonna be a set of indications that psychedelics are for. For the most part they're gonna be, you know, cross indication efficacious, with maybe some nuances. I look at the results of BPL in TRD and, you know, I see this as not just... I see this as a sort of, representative of what we're gonna see in those other indications, you know, that psychedelics are gonna be useful for including, you know, anxiety and PTSD and things like that. Great. Dr. Hendricks, any final thoughts from you? I'll be brief. I think BPL could occupy a niche for rapid, durable interventions with convenient administration. It could potentially serve as a bridge or alternative to existing psychedelics or interventionals. Time will tell. I think the niche there is ultimately for rapid, durable, and convenient administration. Great. Thank you so much. With that, we'll close out this session. You guys have been great. Some really, really good, you know, real world feedback, and so really appreciate you guys being here. I'm gonna turn it over to Jason to for the rest of the session. Yes. Great. Thanks, Kavita. I'll ask AtaiBeckley's team to also join here, along with our key opinion leaders. We have a number of questions that came in, we're gonna start kind of going through those, and I'll pass those along to the appropriate people here. You know, to start, there's some questions that came in from Andrew Jeffries. Srini, I think I'll put this to you, perhaps Kevin to follow up here. He said, "Well, I know that you've said you've run 2 phase III studies or will run 2 phase III studies full stop. During your EOP2 meeting, did you ask FDA if that phase IIb can be a supportive pivotal study, what did they say? Said another way, why wouldn't the phase IIb be counted as 1 of the 2 supporting pivotal studies? All right. Thanks, Jason. Actually, let me start by thanking the panelists. It's great to see all of you, and it was a really exciting discussion, and clearly, you know, appreciate your support and enthusiasm for BPL-003. You know, to answer the question around pivotal. It's actually a more nuanced question than one would expect, right? Let me start by saying that the phase IIb trial was met with a lot of enthusiasm at the agency. I mean, it's always gonna be viewed as a supported trial no matter what you do. When you go to file an NDA, it's really the totality of data that is the key. You know, I've always said it's gonna be two trials. The reason was this anticipation about what would be needed for a safety database, right? The product is being dosed intermittently, but it's being dosed intermittently in a chronic indication, right? These folks are anticipated to get these drugs for an extended period of time, just as we saw with Spravato, right? I mean, that's why you needed a safety database. That said, what are you gonna file with is a slightly different question. Let's just assume that one trial was quite robust, and for whatever reason, the other one was not, you would still file, right? There's no doubt about that. You are looking at the totality of evidence. Again, highly supportive trial. A clear win on one of the phase IIIs, you know, that is what you're looking for. Of course, nothing adverse, you know, there's nothing fancy or nothing special or magical about 0.05 if that, you know, if that's partially what's behind this question. You basically do need that totality of evidence. You know, I don't know, Kevin, if you've got anything to add to that. No, I think you've summarized it well. I mean, the safety database is primary, and actually having two trials that answer slightly different questions, I think is also very helpful. I mean, you know, the landscape is, of course, changing, but I mean, importantly, we had this meeting, and we got our minutes back after publications came out that suggested one-trial approvals. I think that, you know, this is something that we may face later on. For now. Yeah Really for the safety database, we need to keep both. Great. Maybe a follow-up question or slightly separate question. As we think about some of the trial differences between the phase II and phase IIIs, you're evaluating this at a longer time point. You're using a placebo now. One of these studies is doing 2X or, you know, the induction dosing, 2-dose induction dosing. Shouldn't the efficacy delta look even better in phase III compared to phase IIb? Can you talk a little bit about your confidence in that scenario happening? I'll put this again back to perhaps Srini and then Kevin, if you wanted to follow up on that. I mean, we're obviously pretty enthusiastic about the design, right? There's been certainly talk in the space about a potential efficacy delta, affirmative delta that happens when you go with a true placebo versus a low dose. It's speculation at this point, but, you know, these are bigger studies. We do have the two-dose induction. We've got the actual placebo. We're obviously pretty enthusiastic about the results. Now, can we say that we're going to, you know, are we gonna power differently? Are we gonna expect something? I don't know. It's hard to say that right now. We don't have that data. We haven't got enough data from comparators, competitor trials, but still, we're pretty enthusiastic. Yeah. I mean, I just add, I mean, the four-week endpoint is important. I think that's. Yeah ... you know, proximal to dosing. I think that was something we were really keen to get in. As you say, Srini, I mean, I think there are those sort of factors in our favor, perhaps the two-dose induction placebo comparator, but bigger trials, you know, more variance often. I think, you know, our assumption is that these may balance out, and we'll be in a position to be pleasantly surprised if not. The four-week endpoint I think is worth reiterating. That was an important win. It was an important piece of insight that we gained from other programs that are out there, right? Spravato did use a four-week endpoint. Others in the space had tended to use something that's a little bit, you know, that's later, specifically six-week. Just bringing that in, you know, closer to administration for the first trial, replicating what we did in the phase IIb is kinda critical. Of course, it does reduce the time from the second dose to the assessment. Of course, that doesn't change anything about durability. We've talked a lot about durability. Of course, these trials do in fact measure durability out to 12 weeks. none of that changes, but bringing that primary endpoint into four weeks, I think, certainly is, it certainly helps puts things in our favor. Great. Maybe one more question here before we get a few questions to our doctors on the line as well. Both phase III studies are now using a placebo. Could using a placebo work in your favor compared to an inactive dose? The phase IIb had a sub-active or sub-perceptual control of -5.8 points on MADRS. Would you expect placebo to show the same in these phase III trials, something higher or similar? Just if you could comment a little bit around that. Look, I mean, I think I'd sort of err on the same side of similar. I mean, clearly, there are confidence intervals on those effects. We're doing another trial. We're gonna replicate that. I mean, I do think prior evidence in other trials has suggested that an active control may dilute the treatment effects slightly. I think the accuracy of estimation only gets better with repeat trials. Again, I think it'd be nice to be in that position, we're not banking on that certainly in our trial designs. Okay. Great. I'm gonna take a little bit of a different angle here. Doctors Wilkinson, Feifel, and Hendricks will kind of go to you for these, and there's a number of questions that came in. Maybe a few, you know, repeats a little bit, but slightly nuanced, I think, questions here. The first one being, how prepared is the interventional psychiatry ecosystem to operationalize BPL-003? Are practices that provides Spravato ready or getting ready to incorporate psychedelic-based therapies into their practice? That's a question for all three of you. Maybe I'll pick on Dr. Wilkinson to start. Yeah. I spoke to this earlier. I guess the best way I can answer is they're gonna be much, much more ready than they were for Spravato. You know, if the two-hour timeframe holds, it's gonna be much, much easier to incorporate this into a practice that is already using Spravato to treat TRD. Maybe some slight modifications. Obviously, a lot of it depends on how the phase III data unfold. If the two-hour holds, it's, you know, slight modifications, but it's gonna be much more fast to do than it, than it was to get Spravato off the ground. Well- I would definitely agree with that. I think the adjustments needed to pivot from Spravato to a drug like BPL are relatively minor, not zero, but relatively minor. The adjustments needed to pivot from Spravato to a full day, you know, full day experience psychedelic are substantial. I think you're on mute, Dr. Hendricks. Sorry. It's challenging for me. I was gonna mention also, if psilocybin is approved in late 2026 or early 2027, there's likely some paving of the way. In this case, with an intervention that's a bit more or a lot more time intensive. There could be a fair amount more readiness than we anticipate. As mentioned, certainly more than Ketamine. Excellent. Maybe a little bit of a follow-up question here, but again, in a slightly nuanced way. Another question we had that came in was, has Spravato increased interest in interventional psychiatry from a provider perspective, such as from your colleagues that have been practicing in the conventional way for years, and also from incoming residents and or fellows? Just individuals trying to understand if the infrastructure and practitioners will be there to facilitate growth of interventional psychiatry with the introduction of psychedelics. Maybe we'll start with... Yeah, I'll start off with it. I think the answer is a clear yes. I mean, you know, Spravato is inextricably linked with Ketamine and the excitement that that has generated. Really it's continued and just kind of expanded with the, you know, the so-called psychedelics, kind of whatever you wanna call this renaissance that we're in the midst of. There's a lot of interest and, you know, within 4 or 5 years of Spravato approval, again, about 60,000 patients treated with ECT. You know, TMS has been around since the mid-2000s, and there's probably around 120,000 patients treated. I think very quickly. I don't think one is eaten into another really. Again, I think it's just prior to Spravato, TMS, the landscape was, is essentially ECT, which is a very, very important treatment, but there's a lot of cultural baggage. There are some side effects that many patients are unwilling to risk with ECT treatment. Yeah, it's expanded interest. I think it's expanded the number of treatment centers that offer interventional services in one form or another. Maybe go to Dr. Feifel next. Any additional comments? Yeah. I, you know, in terms of the question of whether it's increased interest or... I mean, I don't think, you know, providers think of it that way. Like, "Oh, you know, this is making me think about interventional psychiatry." What I do see is that there were providers who... Obviously, those of us who were doing Ketamine, it was a, you know, just a seamless transition. What was interesting was there's a number of providers now who still don't do Ketamine because it was a bridge too far. You know, the whole idea of, you know, intravenous and, you know, fairly deep, you know, experiences. When Spravato came on board, especially also the FDA approval, I think, you know, gave them that level of comfort, and it was much more of a, I think of a stretch for them. What we do see, clinics now who are kinda, you know, doing mainly traditional things and had been sticking with traditional, you know, prescription med managements, that didn't join the interventional but have now adopted Spravato. I think a lot of providers don't think of it even as an interventional, you know, as that large of a shift in their practice. It's just, okay, you know, I can do this. That's interesting 'cause it's because it's it lowered that bar to adopt a new treatment. Dr. Hendricks, anything else to add? Again, trying not to add anything redundant. Look, I would say that the emerging literature on psychedelics has led to an increase in enthusiasm for psychedelics like Spravato aside. A major medical center, say like UAB, will have an independent clinic dedicated to psychedelics separate from Spravato, and there's no shortage of residents and others who want to know now how can we prepare ourselves for real-world use. I anticipate we'll have a very active clinic that will be engaged with patient populations and training residents and collecting real-world data. I would even say Spravato aside, the literature on psychedelics alone has led to an increase in enthusiasm and conversations around preparedness. Excellent. Thank you. There's a few other questions here. Maybe I'll ask two questions are pretty similar. How do doctors see patient appropriateness for psilocybin versus 5-MeO versus Ketamine? Perhaps a related question here is for your existing Spravato patients, what would the clinical evidence need to look like to prompt a switch to psychedelic-based option? Perhaps, Dr. Hendricks, I'll start with you on that one just to mix things up a little bit here. Okay. I'm a psychologist, keep that in mind, not a physician. I would work closely with physicians to determine, you know, medical appropriateness. Sort of from a psychological perspective, you know, my sense is that given the intensity of the experience with psilocybin or as Dr. Feifel said, how sort of I don't wanna say burdensome, but just that it can be a lengthy and tiring experience, it likely requires a bit more, you know, preparation, and likely psychotherapy. I don't think that that is the case. In fact, we know that isn't with BPL. My first thought is that, the big differentiation again is that we have a shorter acting, more convenient and scalable approach with BPL, and therefore it might be more appropriate for people who are eager for a more convenient treatment. Dr. Wilkinson, anything to follow up there? Can you repeat the question? There was a lot packed in there. Of course. Kind of a two-part. It's how do doctors see patient appropriateness for essentially the different, you know, approaches and modalities, psilocybin, 5-MeO, Ketamine. You know, kind of the follow-up there is for your existing Spravato patients, what would the clinical evidence need to look like to prompt a switch perhaps to a psychedelic-based option? I'll maybe start with the second question. I would say, I think the clinical evidence needs to look somewhat like Spravato, right? If it's way less effective, then there's gonna be a lot of hesitation. The logistical factors are in favor of the, you know, a drug like BPL. We've hit on these themes several times already. If you're having to choose between a session twice a week for four weeks and then once a week, and then, you know, something like that after indefinitely or one treatment every eight, maybe 12 weeks, that just looks a lot different logistically. If you're close to Spravato evidence, in terms of both, I would say delta and overall, you know, improvement in something like a MADRS, then that's gonna be, with your logistical factors in your favor. I think that's gonna be, in your favor. The first question, how do doctors make decisions about, you know, whether to... I don't think you can answer that one right now because all these things, except for Spravato, are still experimental. You know, doctors aren't faced with these questions. You know, the doctors that are involved are running clinical trials, and it's very protocolized and so forth. There's really not any evidence or, in my sense, in my opinion that can help kind of, open the window into doctors' decision-making about these treatments. Maybe as a follow-up there, you know, let's just kind of envision making treatment decisions if and when multiple psychedelics. Yeah. Okay. ... are in the market. What perhaps would kind of feed into that decision-making? Effect size, depth of psychedelic experience, the safety profile, patient preference? Just, you know, kind of maybe talk through a little bit about the criteria there that you would potentially use. Sure, sure. And I hate to sound like a broken record, but some of the factors that I mentioned, maybe an hour ago, you know. Overall efficacy, speed of response, side effect profile on the clinical side, and then the logistical side, right? How often do I need to get retreated, and how long are the treatment sessions? Within those five factors, I think a lot of decision-making will hang on those five factors. Let me kind of flip the question to a sort of a different perspective. A lot of what drives Sorry, providers' decisions are what their clients are demanding, right? Envision a future where a current Spravato provider is now faced with approved psilocybin, approved formulation of, let's say, LSD and approved BPL. And the data are kind of, we project from what we've seen on those compounds so far. And providers are, especially psychiatrists, are conservative. You know, they, you know, if they're doing something and it seems, you know, familiar, there's momentum, you know, inertia, I would say, you know, to not necessarily change. Well, you know, they're gonna have a lot of patients who are gonna be reading about these new, newly approved things, and they're going to be saying, "Why, why can't I have one of these where I come in once every, you know, four months or so, instead of coming in like every week, or every two weeks, to get just to maintain?" If that provider is a little, you know, is gonna push back on that, they're gonna see that client. They're gonna not see that client. That client's gonna go to another place, right? If we take that further among the agents, if you... so we need to do is we need to think from the patient's perspective. This is a different world, you know, than, you know, even 20 years ago. Patients are exposed to this stuff. They're aware. They research. It comes in front of them, you know, you know, on their smartphones. What, which one are you gonna be like especially interested in among the... You're definitely gonna wanna switch from Spravato, so you don't have to, you know, come in all the time. Then among those psychedelics, which one are you gonna pick? I mean, obviously, you know, there's gonna be differences by the time all these programs are done in some of the efficacy and the REMs and so forth. All things being equal, a big factor is gonna be how long do I need to, you know, you know, rearrange my life to be in the clinic. What are patients gonna be demanding from their providers? That's what's gonna make the decision. All excellent points. I really appreciate that. Let's maybe take a little pivot here, to Srini and then maybe as a follow into Kevin. You know, what are the key assumptions that lead to an early 2029 top line readout from the phase II trials for BPL? This is coming from Sumant from Canaccord. Maybe, Srini, you can start there and then Kevin. Sure. Yeah. I mean, obviously we have a lot of experience within the team at this point in getting these trials up and off the ground and, you know, over some shifting time, you know, some shifting regimes as well. We have the records experience to really kind of understand timelines around this. There's still some things that can be unknown. Obviously at this point, we are being conservative on our estimates, and of course, over time we'll be, as these trials progress, we'll be providing some additional updates as to, you know, when top line can, when we anticipate top line. I don't know, Kevin, if you have anything to add. Yeah. No, just to double down on that, really. I mean, I think, you know, the two global phase II trials have taught us a lot in terms of getting drug into country. Schedule I substance is a thing. I think we've got that well worked out. We know a number of really good sites and investigators. I think that helps us a lot as well. I think we're really, we're sort of in the best place. It's, you know, something we've done before. As you say, I think we really need to get those details lined up, and I think we should guide later on. Kevin, maybe as a follow-up there, two-part question here. Would the company, you know, consider that timeline as conservative? Is there a potential for an interim readout for one or both of these studies? Yes. I think it's realistic. As I say, some of the unknowns will resolve themselves, like getting drugs into country and getting licenses approved and that sort of thing. I think it's a realistic timeline based on our prior experience and this indication. Again, you know, in terms of the readouts, what we're talking about here are the top-line results for the core study. Those are the 12-week, double blind phases for both studies. We haven't got it any further on that, and we'll probably update as time goes by. Okay. Great. Maybe staying with you here is another question that came in is, what have you learned about staffing from the clinical studies you've ran so far, and how will that translate in real world practices? How many monitors per patient? Could 1 staff member oversee multiple rooms? What kind of credentials would likely be required? Yeah, that's a really good question, and I think one that is certainly, as an industry we're working on quite carefully. I would certainly separate out, you know, what we need to do in a clinical trial versus what has to happen in clinical practice. In the clinical trial, we are still, you know, learning about this drug. We're still gathering data. The regulators have got some clear guardrails around what should be done. Certainly we need one qualified monitor to support the participant through the trial, through the dosing day. We need a backup person who doesn't necessarily have to be in the room, but needs to be nearby and sort of there to step in if necessary. Again, we have a shorter dosing duration here, so it's not that people have to take comfort breaks or that there's a very long session. I think that is what we envisage for our phase IIs. As I say, that's one monitor in the room. You know, I think that is going to evolve over time. I don't think it's going to be less than one person in the room. Again, we have clear guidelines from regulators about what those qualifications need to be. I do think that in time, we will have a better understanding of what the core competencies for this role are, what the training is that is required, and I think that will begin to define what the qualifications need to be. In some ways, again, given the experimental nature of these compounds at the moment, it is important to err on the side of caution, and we have been cautious in terms of the qualifications. That will change as clinical practice adapts and learns about these drugs. I mean, maybe I can turn that over to the doctors on the call as well, and I don't know if there are any kind of comments or additions that you'd add to that. No. Kevin, I think your point about about the clinical requirements versus clinical trials is very poignant. Of course, a clinical practice often ends up being influenced by clinical trials because the FDA, you know, tends to, you know, especially with drugs like psychedelics where there's gonna be REMs, you know, often requires that the clinical practice replicate what, you know, was shown to be safe and efficacious in the trial. We can assume that, you know. Since I've been doing these studies, I've seen a dramatic downgrading of the monitoring requirements. I think the companies are pushing for less. If FDA, as they see the safety, is agreeing to less so. You know, first studies that I was involved in always had two fully licensed therapists, licensed and specifically trained in the room. At this point, the standard is one licensed, qualified, trained facilitator and one backup who can be monitoring remotely on site, who is, you know, not licensed, especially then. You know, unless that changes, that may be what the requirement is. In clinical practice with a drug like BPL, if I use Spravato as a model and Ketamine, we can definitely monitor multiple patients simultaneously, without a person in every room. That's what we do with our Ketamine clinics. We have 4 or 5 patients that are monitored by CCTV. We have wireless, you know, blood pressure vitals. Patients, you know, as needed. We, you know, we have, we have nurses and physicians go into patients as needed, especially after the first time. Maybe for the first experience, it's new. There's a lot of anxiety. You might need a monitor in. Once patients kind of become familiar, and they're coming in for their, you know, you know, quarterly or, you know, 4-month dosing, for 2 hours, they can definitely be in the room without somebody from a clinical point of view, and being just monitored by a less than 1-to-1 ratio. We'll see. That'll probably happen as the drug is out and, you know, and AtaiBeckley and other companies are able to show, you know, good, you know, safe results. Those REMs may loosen over time. Mm-hmm. You know, I'd like to just add one point to that. I think the short duration psychedelics are particularly well suited, I believe, and of course, I'd like to get the take of the KOLs on the line, but they're particularly well suited to having less monitoring. The reason for that statement is that if you look at the data that we've generated, the really the most intense period of the psychedelic experience is very short for these drugs. I mean, we're talking about this 2-hour thing, but that is, you know, wheels up to wheels down. That's everything, right? If you're looking at, you know, what we refer to as SIRS, which is Subjective Intensity Rating Scale, and things like that, when you're in the 5 and above range, for BPL, it's what? 30 minutes, maybe 40 minutes. If you think about like a psilocybin or something, it's several hours, right? It's many-fold longer even, you know. That may allow us less monitoring over time. I mean, it's just, you know, you can watch the patient. You can watch them remotely. If something's going on, go in there and settle them down as appropriate, as opposed to having to talk them through a really extended period of time. Again, I throw that out to the KOLs to get their reaction to that. I'll speak to that a little bit. Not only the monitoring, but just the physical infrastructure demands. You know, it may not be an obvious problem, but if you have an 8-hour session where patients are in an altered state, you know, one of the, you know. How do you get patients to go to the bathroom, right? Right ... long-acting psychedelic companies approach us and, "Hey, you know, we want you to run these trials." I said, "Okay, you have to have this special space, and there has to be an adjacent bathroom because you know, we don't want patients who are in an altered state stumbling through the hallway and interacting with other." You don't have that same problem with, you know. If by 90 minutes, you know, 98% or whatever of the effect has resolved, as your CMAX data suggest, it's not really that. You know, most human beings can Can- Yeah you know, can wait for 90 minutes. That is another aspect to the just the logistical facility that a shorter period allows for. I'll take that one step further. On the monitor's end, you know, if the FDA would require a licensed facilitator to be in the room at all times, if you, and this is, and this is something you don't, you don't foresee, but when you, when you start getting down into the weeds of the study, and you're thinking of the logistics, you realize you have an issue because if you have a 6 or longer hour session, the, those monitors need to take a break, right? If you need that means you need to have a backup available. If you know, and let's say like us, if we're contracting, like that's a serious problem because you're paying for somebody who's only gonna be you know, stepping in for short periods of time to give the monitor a break to go to the bathroom or to grab something to eat. Whereas if it's a 2-hour, single monitor can do that. You put a half-hour gap between patients. They go, they take a break, and they can go back in for 2 hours without needing a break in between. The little things like that are not obvious, you know, from the surface, make a big difference in the economics. I'm gonna add to that too. As I mentioned before, I'm a psychologist. You might wonder how a psychologist became interested in drug development. I would say that it started with psilocybin and the, you know, impression or intuition that psilocybin could lend itself well to adjunctive psychotherapy or that some sort of preparation is needed, some sort of so-called integration is also needed, and that it could be helpful to have a trained mental health professional in the room, especially when difficulties arise. I think in the case of BPL, it's a completely different ballgame. I don't think Atai's trying to make me redundant or put me out of a job, but I don't think I'm needed in this case. Although I still find the subjective effects, the experiences that people have to be fascinating, and the mechanisms are incredible. It's really amazing to hear the sort of stories that people have and to see this sort of rapid transformation. I do think again, a rather significant upside is that the psychotherapy may really may not be needed at all, which may not be a win for me as a psychologist, but certainly a win for the patient populations. That's what I want more than anything else. That's wonderful. A great conversation there. Let me another kind of general question come in, and Srini, I'll pose this to you, then maybe Ryan as a follow-up as it pertains to scheduling actually. How are, how is AtaiBeckley working with lawmakers to reschedule DMT? Will this be done prior to approval or after approval? How long will this take? There are a number of organizations that are proponents of advancing psychedelic therapies. What type of role are they playing in general, and are they helping to lay some of the groundwork for scheduling of these drugs? Srini, maybe you can take that, then, you know, Ryan, if there's any follow-up there. Yeah, absolutely. Let me start with kind of the statutory process here, right? What does Schedule I mean? It means that it's a drug that has an addictive profile and also has no approved medical use. That latter part is really key. What typically happens, and you know, this has happened before for things like gamma-hydroxybutyrate, but also THC, what happens is that the drug gets approved by the FDA. The FDA then petitions the DEA with, you know, with an analysis called an factual analysis, etc. The DEA then typically it's kind of a, you know, it by definition, the definition of it has shifted then, right? It's been approved. The FDA, the DEA will then, you know, down schedule that product. Going back to Gamma-hydroxybutyrate, that is still a drug abuse. It's still Schedule I, but as of in its approved form as Xyrem, it is down scheduled. Just that product is down scheduled. The compound itself is not. We're not necessarily advocating for DMT itself per se to be down scheduled. We want our products, whether it's DMT or 5-methoxy-DMT, etc., we'd want our products at BPL-003 and VLS-01, just like Compass presumably wants COMP360 to be down scheduled, not psilocybin per se. It's a slightly nuanced answer. The DEA approval process statutorily is 90 days. Once the drug is approved, that is put forward by the FDA to the DEA. That's a 90-day process for them to do the differential down scheduling. That's, that's the general thing. I'll actually let hand it off to Ryan here to kind of give some of the, some additional color as well as some of the organizations and some of their efforts there. Absolutely, Srini. Thank you. I think you nailed obviously the, the big picture framework. The only things I would add is that running parallel to the federal effort, of course, is also the state-specific efforts. We're actively engaged with APP and other psychedelic developers to ensure a systematic approach to communal development challenges, including descheduling. I would say that our general view at AtaiBeckley is that we need to be and will be actively engaged in the lead up to commercialization to ensure that the amount of time and friction between a potential FDA approval and the, again, as you said, narrowly tailored descheduling at the state level is maximally reduced so that the patients get the benefit as expeditiously as possible following approval. I would say the only other thing to add, we do anticipate having the benefit of following certain longer duration psychedelic developers like Compass Pathways with COMP360, which will presumably help us refine our specific approach to this issue for BPL-003. Okay, great. Thank you, Srini. Thank you, Ryan. Another question here is, and Srini, maybe we'll pose this to you and then Kavita, is AtaiBeckley entertaining any conversations with big pharma or other potential partners to distribute or commercialize the product? Just maybe talk through a little bit what potential commercialization might look like there. Yeah, I mean, obviously we can't speak to any conversations until they become, until they get to a certain point. You know, big picture, there has been a lot more inbound interest in this space. I think a lot of that was driven, of course, by Spravato's success over the past couple of years. It's the, you know, the interventional psychiatry pharmacotherapy space has really kinda hit the radar screens for many companies. There's definitely interest from that perspective. Of course, you know, that the other catalyst here was AbbVie with the Gilgamesh transaction a little while ago. Those are things that really have driven it. You know, we will see and of course, we'll advise appropriately as things as things change there. I'll actually let Kavita kinda talk through the commercialization bit, which I think is unique for us here, such that it's not a requirement really to have a big pharma partner for commercialization. Yeah, absolutely. Thanks, Srini. I'll bring back some of the commentary I had earlier. You know, we are fully prepared to commercialize alone. I say that because, you know, this is a market, I showed some data, this is a highly concentrated market in treatment-resistant depression, interventional psychiatry. Even just looking at the Spravato numbers, you know, I think it's remarkable. We think about the 80/20 rule. This is actually, you know, 10% of the sites today that are treatment centers that are, you know, REMS certified Spravato treatment centers are actually yielding the majority, 75% of the prescriptions. You know, I think that again, it sort of underscores that there is a very concentrated high volume treatment center opportunity here. Because of everything that you've heard today, you know, we believe that the operational fit within those that current infrastructure makes a lot of sense, and we are uniquely fit to slot into that. So yeah, we are definitely preparing for commercializing alone and developing those relationships and market readiness as we speak to be able to do that. Thanks. Okay, great. I'm gonna move on to another set of questions from Pete from Cantor. Kevin, maybe this is a little bit of a repeat here, but perhaps we can just talk through this one a little bit. For the phase III studies, are you using sites that are psychiatry experienced but not necessarily psychedelic experienced? If so, what specific training or monitoring were you put in place to ensure consistent prep and dosing date procedures? Some examples, you know, being patient prep, handling acute effects, discharge criteria, etc. Yeah. Yeah. Look, I think the first aim is to use as many of the sites that we have worked with before, who are not only psychedelically experienced, but I think understand the BPL product or the VLS product. I think that's, you know, that's our first step. There will of course be others that haven't worked with BPL before. I think we are really benefiting from the fact that there has been a great capacity build due to the other phase III trials that are ongoing at the moment. Kind of globally, we are seeing greater bandwidth in the number of sites. That isn't to say that we aren't because of competitive, you know, influences at the sites. We aren't gonna take some sites that are new to this endeavor. Again, I mean, we've stood up a number of psychedelic naive but very experienced investigative sites on previous trials. I think there are a couple of things that really help us here. The first actually is the central rating. That is consistent for our primary endpoint and our MADRS scores. I think the central rating, although it's operationally complex, really helps us. Obviously we supervise that very carefully, and we do surveillance of those scores, but we have fewer raters, and there is more consistency. We also have a very comprehensive, you know, participant support manual and training program, and that actually has got some patient-facing elements to it. It's also got some, you know, training of the monitors, and that's a key piece. I think making sure that the monitors are trained because actually that they deliver the support in a consistent way is an important piece. That really speaks to expectation management, you know, sort of, equipoise around dosing and uncertainty and that sort of thing as well. I think there's a, there's a lot of effort that we've put into managing that process. Of course, we record those sessions, and we do assess those as well for consistency and quality, and we remediate if we need to. I think the other part is on adverse event monitoring. I mean, this is a, a sort of a strange place to be. People have rather you know, kind of strange or difficult to describe adverse events. Again, the... I mean, I think the field has really evolved as we've grappled with this problem, although it's not new. I mean, I think Ketamine's provider had it. There are a number of other compounds that have dealt with similar things. I think making sure that we capture those adverse events in a way that is interpretable across sites. That's not really a new site, old site problem. It's just a quality issue that we are very focused on. I do think we're pretty confident that we'll take a sort of small percentage of new sites, but that we've got an onboarding process that is well set up to accommodate them. Okay, great. Thank you. Move on to another question here. Start with Srini, and I think it'd be really good to get our KOLs also to comment on this. In a real-world practice setting, what would drive retreatment or redosing with BPL or other psychedelic agent? Would it be patient driven with patients reaching out to the clinic if symptoms occur? Maybe just speak a little bit about that. Srini, maybe I'll start with you and perhaps Kevin to comment on that, then I think it'd be great to have our doctors on the line also. Yeah. We are, you know, there's been several points where we had some interesting discussions with the agency that we are keeping close to best because, you know, for competitive reasons. Obviously, some of this will be disclosed over time. The specifics on the retreatment criteria is certainly one of those things that we don't wanna get into in detail at this point. We have obviously mentioned that it can be 8 or 12 weeks. Most, to the best of my knowledge, all the competitors are actually focused on 12 weeks. Because of the short duration, the short duration nature of BPL-003, the question is can you actually help patients that are basically kind of losing efficacy sooner? It's an option that may be available to us because of that short duration. That's the only thing that I think we can say in terms of the details. I don't know, Kevin, if you wanna add anything to it. Otherwise, we can defer to the KOLs for how things can happen in the real world. Yeah, I think that's right. I wouldn't really say much more about that. I think having some flexibility, and we've got obviously a sort of a range that we're thinking about, but the data will really drive where that lands. I'll hand it over to the clinicians for your thoughts as well. Well, I think that, I think there's gonna be parameters, probably, you know, driven by FDA REMS and insurance. You know, with TMS, there's usually a minimal interval period before an insurance payer will be willing to reapprove another round with Spravato, for example. I had mentioned that, typically, once a week maintenance is maximal, which for some people, given its short durability is, isn't enough. From a clinical point of view, there, you know, there's two models. One is, one is, you know, reactive when a patient's, you know, starts to feel that they are losing some of that benefit. Given those other parameters are, you know, eliminated now, which is. If somebody starts to feel they're drifting back, you know, they call. They come in for a. Which happens a lot with our Ketamine clinic because it's out of pocket and people don't wanna be scheduled regularly. If they're doing well, you know, they'll kind of play it by ear, especially if they've get a point where they can go fairly long duration. Then there's the further prophylactic model, where you're scheduling it, you know, to prevent any relapse. You know, I think that probably it, what'll end up happening, if it's driven by clinical need, patients will figure out where their, where their pivot point is, where they need to come back, and those will be kinda scheduled in advance. You know, mine lasts about, you know, three months, and then I start to notice a decline, so I schedule, you know, out in three months 'cause they, you know, they wanna be in the books for that. I'll just agree with that all and add to that also perhaps the, you know, point for enthusiasm here, at least on my end, is. Mm-hmm ... the ability to intervene earlier before there's a sort of a lengthy period of demoralization after trying one SSRI or SNRI or some other treatment after another that really doesn't work. There will be parameters as mentioned, but, I think we should be optimistic about being able to intervene earlier and prevent that lengthy period of demoralization. I'll add on with respect to what David said about the reactive versus the kind of preventive approach. I think the reactive works pretty well for Spravato because the interval's so short. You know, you're seeing patients maybe once a week, once every other week, and at most in our clinic, once every four weeks. I think it is gonna be one of the slight shifts that I think would be important for patients to where, you know, if you get a dose of BPL, maybe you have a telehealth appointment that you schedule for four weeks from then. You kind of assess where they are maybe eight weeks from then, and try to kind of, before patients really fall back to the depth of the point that they were before, try to catch them on, you know, as that slope just starts to become negative a little bit and you can get them in quickly. That's my thought about the reactant. The Spravato will lay a lot of the groundwork. There will have to be some tweaks as to the best treatment model that providers can offer. Excellent. That very helpful. moving on here, and Kavita, I think I'm gonna send this one to you. There's a question that came in. Given the rapid onset and relatively short session time of BPL, what do you see as the minimum durability threshold needed to compete with the 20, 30, 40, maybe even 50-plus annual Spravato visits? Is 3-month durability a win? We just need to comment a little bit on that. Sure. I would say unequivocally yes. You know, when we think about, and we shared some information that on average, Spravato patients are on weekly maintenance, bi-weekly or weekly maintenance. Think about it, coming in to a clinic with the same 2-hour duration, same constraints, but every other month, that in of itself is game-changing, and it was validated. We talked to a lot of patients. We talked to a lot of, you know, and did some research on this, and they absolutely echo those comments. While an even broader treatment frequency even better, I think every other month is absolutely a win, as you said, you know, for patients as well as for clinics. Appreciate that. Thank you. maybe going back to our clinicians, a question that came in, if BPL reproduced its phase II clinical profile in phase III, what proportion of your TRD patients would you recommend this for? What patients would be good candidates versus Spravato, for example? maybe Dr. Feifel. Looks like you came off mute first, so we'll go with you. I mean, assuming that, you know, it's Spravato versus BPL as we know it from phase IIb, I mean, who would I not? I mean, what I'm trying to think of why I would recommend somebody stay on Spravato. Nothing's coming to mind. I mean, you could do, you know, you get these great effects, generally quicker, and longer duration. I mean, I'll have to think, I'll have to think hard about some situations where that wouldn't be a no-brainer recommendation. Even if I didn't recommend it, as soon as the patients got wind, they'd say, "Hey, you know, are you gonna be offering this here? Because I'd much rather come in once every few months. I would agree with that. My response to that question would be all, you know, obviously considering the sort of inclusion and exclusion criteria that are already a part of the trials and the REMS. I don't see any reason why we would recommend Esketamine before BPL. In fact, I'm more enthusiastic about BPL than Esketamine for a number of reasons. I think this could potentially take over as the treatment of choice. Yeah. Maybe, Jason, if I can add too. You know, I think we talked about the broad treatment-resistant depression population in the U.S., and penetration within that with Spravato or a FDA-approved TRD treatment is so small. I think, you know, absolutely, the low-hanging fruit here is those who are not getting the clinical effect from Spravato or can't, you know, deal with the weekly visits or bi-weekly visits. I think there is a much larger cohort potential that could potentially benefit from BPL as well within the TRD landscape. Very helpful. Okay, great. Thank you. Moving on to another question, and Kevin, I'll pose this to you. For BPL, can we go into the patient visit time to check in, the time to prepare for the therapeutic session, interactions with monitors? Just can you provide some insights into the patient experience before and after being dosed with BPL? Yeah, sure. I think, we've sort of touched on this already, but I would separate out, you know, maybe what we're doing in the trial, in particular the core trial, with what we're doing in the open label and what might ultimately be how we do this in clinical practice. I mean, at the moment we're taking, we're doing certain things in the trial, like collecting PK that aren't relevant and won't follow through into clinic. Let's think about a patient, you know, who's coming in for maintenance therapy, so has had a number of doses before. What would that look like? We would expect typically a kind of an intake, so that may, that may be a check-in the day before, maybe on the, on the day where we check in on the patient's mental state, any major life events. Generally just checking in before we dose the participant. There's the dosing itself and the monitoring thereafter that. Obviously we're striving for a two-hour discharge. That's, that's really where we're sort of aiming for for that. I think, you know, there would be in terms of sort of safety structures around that, clearly the monitoring is gonna be a key factor. Like Spravato, blood pressure assessments and that sort of thing will be important as well. You know, the safety data that we have to hand so far suggests that there aren't any other safety interventions that are gonna be required for the majority. You know, we know that blood pressure and that sort of thing is something that we need to monitor. We certainly, as I mentioned, offered intervention with, say, benzodiazepines for anxiety or agitation. None of that was required in the phase II. I think those things are kind of in the back pocket, but it seems like the rates of their use will be low. And really it's the quality of that monitoring and a brief intake that are gonna be the most important. And I do expect that patients will become familiar with the dosing sort of logistics and time course over time. That's... We're trying to build that in even to our protocols to have sort of flexibility, as we move into latter dosing, not to take it away entirely, but clearly the first time you have this dose is gonna be different to the fifth time you have this dose. I think there are gonna be... we're gonna see that evolve over time. I wanna hand this also off to the clinicians. You've dosed many of these patients for our trials, and you have a much more hands-on set of experiences. I don't know if you have anything to add to that. Well, I think that was gonna be a very comprehensive answer then. Okay. Very good. Another question here, Ryan, I'm gonna pose this one to you. Can you talk a little bit about our IP estate around BPL and how maybe it would prevent other branded 5-MeO-based drugs from entering the market? Absolutely. Happy to, Jason. I mean, I think as a prefatory point, we're here in service to our mission, which as I mentioned before, is to transform patient outcomes by developing rapid acting, durable, and convenient mental health treatments while executing in a way that drives meaningful value for all of our stakeholders. I'd also note that the depression and broader mental health markets are massive. In short, we don't view competition as a bad thing at all, and we root for other psychedelic developers. In a perfect world, the products reaching patients are those that can be predictably executed and which drive the best health outcomes as compared to an effective placebo. This is an area in particular where we believe that we and BPL-003 in particular stand out. That said, we were founded on the traditional biotech belief that a strong patent estate is absolutely critical to ensure that we can effectively finance, thereby enabling us to achieve that mission. This was a key reason that I was brought on early in the company's existence. A strong patent estate comes from having the right strategy and executing well on it. We've discussed our approach and the fruits that my talented team has produced in the form of numerous issued and Orange Book listable U.S. patents. In my personal view, this is the type of pointed question not asked enough of drug developers, particularly in the psychedelic sector. While I'm not privy to any non-public information of those other developers and wouldn't comment on any specific third-party patent estates either way, I think the answers in some cases may well surprise you. I would note that as part of the comprehensive IP strategy we undertake here at AtaiBeckley, as noted previously, in terms of our Orange Book strategy, as well as securing issued U.S. patents on alternative salts, formulations, routes of administration, and use in alternative indications, is to ensure that we've got a strong foundation for commercialization and potential expansion while having multiple layers of defense, all of which we believe will make it very difficult for would-be competitors to design around our patent estate. Wonderful. Thanks, Ryan. Appreciate that. We're coming up on the hour here. I think we'll have one more question for Kavita and then a final question to our clinicians on the call. Kavita, what pricing bands or kind of pricing considerations are we or are you considering for 003 at this stage? Any kind of high-level commentary there would be helpful. Sure. It'll definitely be high level. You know, as we know at this stage, we're not at a position to provide any specific pricing guidance. What I will say, and what I shared in the presentation earlier, is when you look at kind of our closest proxy, at least in the market today, Spravato, and you see the actual utilization in the real world of what the average patient is, the dosing frequency, you know, often monthly at the higher dose, you're in a range, based on our data of $60,000, maybe even well north of that. This is WAC pricing. Pricing is complicated. There's a lot behind that. What I would say is, you know, if we truly deliver on this trifecta of benefit, so again, rapid acting, very durable compound that is convenient, you know, this 2-hour window and convenient for patients and clinics, we believe that there is opportunity, for premium pricing potential if that value is delivered. So I would just leave it at that at this point. Thank you. Perfect. All right. I think one last question here, and I'll pose this to our clinicians on the call, before handing this back to Srini to close. Is just, you know, perhaps some final thoughts on the psychedelic field and what you're most excited about moving forward. Just as some kind of parting thoughts before we close. I'd love to kind of hear those. Perhaps, Dr. Wilkinson, you can start just 'cause you're first on my screen here. Yeah. Thanks. Well, I'm just excited that we're finally in a space where we have lots of different things with different mechanisms. For a long, long time in drug development, it was just me too drugs. It was, you know, adding a methyl group to some SSRI or something like that. We do owe a lot to the Ketamine Spravato story because that really, I feel like opened up the field to really just thinking about, hey, one dose. I mean, a couple of times in this call we've said, well, you know, Spravato is not very long acting, but from a historical perspective, it is, right? You had a drug that has a two-hour half-life and it could keep people well for a week. That was a really kind of paradigm shifting reconceptualization. I'm, you know, I'm excited about the short acting and the potential for long durability. Perhaps Dr. Feifel, go next. Yeah. I mean, I am just excited about, you know, practicing in a field where I feel I have really powerful weapons, for maybe a lack of a better term, to fight this monstrosity of a mental illness, which is such a scourge on society, and doesn't seem like it's gonna be going away anytime soon with the nature of our society. You know, I actually went into psychiatry. One of the reasons I chose it, Was that I believe that it was on the precipice of a revolution. Neuroscience was advancing so rapidly, and I thought this is going to translate into great changes. You know, not many students were choosing psychiatry. I actually published a paper about students' attitudes because we couldn't fill our residency slots. About a decade ago, a little over a decade ago, things were so gloomy because companies were pulling out of R&D. In fact, there was a New York Times column by a psychiatrist who talked about the innovation crisis in psychiatry. It was a really kind of gloomy time. I said, "I'm a decade into my career, and I'm still writing, you know, prescriptions for the same essentially the same drugs that my mentors were writing when they were residents." You know, they got a little fancier and so forth, but they were essentially the same mechanisms of action. I thought that, "Wow, this is I may have miscalculated here." Thankfully, look, here we are. You know, I describe this as sort of the Cambrian explosion of new treatments where we've got a embarrassment of riches of all these new compounds. They are revolutionary. The If I had to precipitate down to what am I excited about, sitting across the desk from a patient that I know I've got something that will change their life where I did not feel that before. I almost felt like I was just trying to string them along, say, "Well, what if we just change the dose here? Or we add this drug, we add this drug." I wasn't really convinced that I was really doing something dramatically different. Now I just feel like I've got stuff. What's coming down the road, I'm gonna really have some good stuff. Dr. Hendricks. There's a lot I can say about this, but let me just start by saying my interest before I knew psychedelics existed was in a concept known as quantum change. That captures this idea that sometimes people do change rather suddenly and dramatically, and this change is durable. It happens or happened so infrequently, it was fair to say that scientists didn't really understand that process. We have fictionalized versions of it in the case of, say, Ebenezer Scrooge. I was always fascinated by this story that sometimes people can change dramatically and for good. When I came across the literature on psychedelics, my first thought was, "Oh my goodness, we can actually schedule quantum change for a time and place." Now, I recognize that not everybody has that experience, right? Like any intervention ever, not everybody will respond. I think prior to psychedelics, usually in a clinical trial, if we had a successful intervention, that intervention would in fact have ultimately failed less than the placebo, but was still not successful for most participants. That's demoralizing for the clinician when we know that even our best treatments won't work for most. I think with psychedelics, the tide is turning, and as David mentioned, we're at this place now where we might be able to offer treatments that work for most people. Not only that, but they speak to a mechanism of action that can cut across diagnoses, and that's likely because potentially these interventions are getting at the core of the mental health condition rather than only addressing the symptoms. Personally, I think one thing that makes psychedelics quite unique is that they get at deeply held personal values and how we form meaning in life, and allow people some clarification of these values and perhaps alignment of their behavior with those deeply held personal values, which is a good thing. I'm quite excited. I also do want to say again that I think in the case of BPL, we have a very unique psychedelic that is not just, say, psilocybin in a shorter acting form. I think it has a number of unique properties that could make it especially amenable to a wide range of mental health conditions and in a way that is scalable to the clinic workflow. As this conversation has gone on, I've become more enthusiastic as we're talking about these things out loud. It's a really exciting time to be involved in this space because I think we're on the precipice of offering a treatment that could really work for the majority of people and that the majority of people can access. Wonderful. Thank you very much. A special thanks to, you know, Dr. Hendricks, Dr. Wilkinson, Dr. Feifel for joining us today. Insights were just incredibly valuable, meaningful, impactful. Really appreciate you joining. With that, Srini, I think I'll pass this back to you for some closing thoughts before we end today. Yeah. Let me start by actually reiterating what you just said, Jason. Thank you so much, Dr. Feifel, Hendricks, and Wilkinson, just for your time, which was significant, your enthusiasm, and also for all those insights. I wanna thank the audience as well for their interest and all the great questions that we received over the course of the call. Thank you to the team for making this webinar possible, obviously, and all the hard work it took to get the company to this place. 2025 was transformative for the company. A lot of things happened. A lot of great things happened. 2026 promises to be so as well. We've got, you know, we're getting this phase III program up off the ground. We're awaiting the data for BLS-01. It's also worth mentioning it's gonna be an exciting time for the space. We've got some phase III readouts will be coming up. I have had some, and we'll have others as well, so it's really important for the patients. Stay tuned, and we look forward to continuing the discussion with all of you.