Good morning, welcome to the Atai Life Sciences Second Quarter 2021 Financial Results and Corporate Update Conference Call. Currently, all participants are in a listen-only mode. This call is being webcast live via the news and events section of the company's website at www.Atai.life, and is being recorded. For opening remarks, I would like to introduce Greg Weaver, Chief Financial Officer of Atai Life Sciences, p lease go ahead. Thank you and good morning. Welcome to our second quarter 2021 Atai Life Sciences financial results and corporate update conference call. The press release reporting our financial results is available in the investors and media section of our website at www.Atai.life, and our quarterly report on Form 10-Q, ended June 30, 2021, we'll file today with the SEC. Joining me today are Florian Brand, our Co-founder and CEO, Dr. Srinivas Rao, our Co-founder and Chief Scientific Officer, and Christian Angermayer, Founder and Chairman. During today's call, we'll be making certain forward-looking statements that are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. While these statements represent management's current expectations and projections about future results and performance as of today, Atai's actual results are subject to many risks and uncertainties that could cause actual results to differ materially from those expectations. In addition to any risks highlighted during the call, these statements are subject to various risks that are described in our filings made with the Securities and Exchange Commission, including our final prospectus filed with the SEC on June 21, 2021. You're cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, August 16, 2021. Except as may be required by applicable law, Atai disclaims any obligation to update such statements, even if management's views change. I'd now like to turn the call over to Atai's CEO, Florian Brand, Florian? Good morning, everyone. Thank you all for joining our first earnings call following our successful completed IPO on NASDAQ in June, where we raised $259 million. We are thrilled by the enthusiastic response to our mission from the investor community, we intend to use these proceeds to continue advancing our decentralized drug development platform in two ways. First, by executing on our existing pipeline, second, by continuing to incubate, acquire, and invest in new programs and enabling technologies. With our unique approach, we aim to become the leading drug development company focused on mental health. We will do so by transforming and advancing the treatments of patients with the ultimate objective to heal mental health disorders so that everyone everywhere can live a more fulfilled life. Now it gives me great pleasure to introduce you to my visionary co-founder and our board chairman, Christian Angermayer, Christian? Thank you, everyone. With my co-founders and the entire Atai team, I share the common aim of transforming the treatment of mental health disorders and exploring solutions offered by unconventional approaches, including psychedelic compounds. I want to take a few moments to discuss Atai's origin and my commitment to Atai. In this context, it is important to emphasize that I'm not only part of the founding team, but also made a significant investment in Atai myself. As many of you know, everything started with my own first psychedelic experience. This experience was, in short, the single most meaningful experience in my entire life. In addition, my friend and our co-founder, Lars Wilde, who suffered greatly from treatment-resistant depression, found healing in psilocybin therapy. Both experiences formed the basis for my desire to invest heavily in rigorously researching therapeutic potential of psychedelics for mental health disorders. I hope you leave this call with a real appreciation for both Atai's progress to date and what I hope will be an even brighter future to come. While I leave it to Florian and Srini to elaborate on the details of our achieved milestones, I want to emphasize what makes me most proud. Atai is aiming to help solve one of the biggest problems in healthcare, mental health disorders. More than 1 billion people globally suffer from depression, addiction, PTSD, anxiety, and other intractable mental health diseases. That is just the official number. The unofficial one is most likely significantly higher, as mental health issues are unfortunately still a stigmatized topic. We have built a well-funded company in the young psychedelics industry and have more than $400 million to continue advancing our 11 programs. We have a rich business development pipeline and are aiming to add more programs over time. All of our drugs, both the psychedelic ones and the non-psychedelic ones, have prior evidence in humans, which helps strengthen the indication for the outcome of our trials. Because of our portfolio approach and our extensive pipeline, we expect continuous news flow with 18 R&D catalysts over the next 18 months. Our partnership with Otsuka illustrates Big Pharma's interest in psychedelics. While we strive to keep control of our assets through phase III, and we are, as you know, well-funded to achieve that goal, we believe that this is just the first step and more pharma partnerships are possible. In short, I'm very convinced that Atai has the potential to become the leading mental health company globally while building value for our shareholders and other stakeholders. Let me now hand it back to our CEO, Florian, who together with our CSO, Srinivas, and CFO, Greg, will provide additional updates on our business. Thank you, Christian. Allow me now to provide a few introductory comments. Srini will review highlights from our drug development pipeline, and Greg will provide the quarterly financial report followed by the Q&A. For people not yet familiar with our company, let me briefly give you an overview of Atai Life Sciences. We founded Atai three years ago as a response to the significant unmet need that we witnessed firsthand ourselves with friends and family members suffering from mental health disorders. As you know, we operate our business in a decentralized model and utilize enabling technologies such as digital therapeutics. This allows us to support and accelerate the development of compounds in our companies. These are all companies we have either acquired, controlling or significant interest in or incubated de novo. We have a disciplined program selection process that is focused on differentiated mental health opportunities and aimed at increasing the clinical probability of success. On an asset level, we are focused on developing compounds with prior evidence in humans. Combined with our unique portfolio approach, which is designed to avoid binary risk, the Atai pipeline can be both innovative and diversified. Process also incorporates a milestone-based approach to capital allocation. We have already demonstrated our ability to capture value this year by partnering with other world-class organizations focused on mental health. One example of this is Perception's licensing deal with Otsuka, an industry leader in innovative mental health therapies. This deal represents the first major partnership between a biopharmaceutical company developing psychedelics and large pharma. In only three years, we have aggressively built a pipeline of 11 development programs and six enabling technologies. We believe that several of our target indications have a potential market opportunity of at least $1 billion in annual sales each, once approved. Outside of our current focus indications, we see significant untapped business opportunities around indication expansion with an additional estimated market potential of $18 billion by 2026. We intend to invest in these indications for our most promising compounds to optimize our portfolio and maximize shareholder value. Looking forward, it is important to highlight the density of our news flow. We have 18 R&D catalysts over the next 18 months, a result of our portfolio approach and our extensive pipeline. The two most imminent upcoming milestones are, first, Compass Pathways, that is expected to provide top-line results on their phase II-B study in Q4 of this year. Second, Recognify Life Sciences, that has initiated a phase II trial and expects to have data by the end of the year. In addition, we plan to initiate Perception's phase II trial for TRD and DemeRx's phase I/II OUD trial still in this quarter. Additionally, we plan to initiate three phase II trials and four phase I trials next year. With a very strong cash position, we are well equipped to maintain our leadership in developing treatments for mental health disorders. I will now turn the call over to Srini for a more detailed update on the Atai pipeline. Thanks, Florian. As Florian has highlighted, we have a broad array of exciting assets in or nearing the clinic. On this call, I will focus on the programs with the most near-term visibility and highlight upcoming milestones, starting with Perception Neuroscience. Lead compound for Perception is PCN-101, a formulation of R-ketamine. R-ketamine is a glutamatergic modulator being developed as a rapid-acting antidepressant with non-dissociative properties and the potential for at-home use. This is in contrast to esketamine, marketed as SPRAVATO, which must be administered only in the clinic. In preclinical models, R-ketamine has demonstrated higher potency, greater durability, and lower abuse potential compared to esketamine. The recently published results of an open-label, seven-subject trial in patients with treatment-resistant depression, or TRD, using IV R-ketamine supported the hypothesis that R-ketamine may be efficacious at sub-dissociative doses, in contrast to esketamine. As we've mentioned before, we're excited about these potential aspects of differentiation, particularly from the perspective of the scalability and commercial potential for a product delivered at home. In February 2021, Perception announced positive phase I results demonstrating the safety and tolerability of PCN-101 in 58 subjects treated at doses of up to 150 mg IV. The compound was well-tolerated, and there were no serious adverse effects reported. The pharmacokinetics of PCN-101 in plasma were found to be approximately dose proportional. The study demonstrated that PCN-101 required substantially higher doses to induce perceptual changes compared to esketamine. We anticipate initiating our phase II-A trial of PCN-101 in Q3 2021. This randomized, double-blind, placebo-controlled trial testing an IV formulation of R-ketamine will be conducted across 13 sites in Europe and aims to enroll 93 patients diagnosed with TRD. We anticipate the study running through late 2022. In parallel, we intend to conclude a phase I bioequivalent study to bridge from the IV formulation to a subcutaneous formulation of PCN-101, one that we believe will support at-home use. Next, Recognify Life Sciences is developing RL-007, an orally available cholinergic, glutamatergic, and GABAB receptor modulator. In aggregate, RL-007's complex pharmacology is thought to alter the excitatory inhibitory balance in the brain to produce procognitive effects. We're developing this compound for the treatment of cognitive impairment associated with schizophrenia, or CIAS, which is a challenging indication with significant unmet need, as no drug therapies are presently approved for this condition. In April 2021, Recognify initiated a 32-patient, phase II-A proof of mechanism study for RL-007 after receiving IND clearance from the FDA to commence U.S. clinical development for the treatment of CIAS. The exploratory study is designed to evaluate the effects of RL-007 on safety, tolerability, and quantitative electroencephalogram, or qEEG-based measures that are viewed as biomarkers for cognition. More specifically, the objective of the trial is to extend the results of a previous study involving a scopolamine challenge in healthy volunteers. In addition to observed improvements in verbal memory, RL-007 administration resulted in a spectral shift on qEEG from a lower frequency theta band to higher frequency alpha and beta band oscillations. Further, we're investigating the effects of RL-007 on several evoked potential measures, including mismatch negativity and P300, the latter in response to an auditory oddball task. Ultimately, we're looking for a confluence of data consistent with procognitive effects when all cohorts in the phase II-A trial are analyzed. Such top-line data, which are anticipated by the end of the year, will allow us to progress confidently into the proof of concept study. The latter, it will be a double-blind, placebo-controlled trial focused on more traditional cognitive endpoints, including subsets of the MATRICS battery. Next, GABA Therapeutics primary program is GRX-917, an oral formulation of a deuterated version of etifoxine, the latter a compound that has a long history of prescription use in France and other countries for treating anxiety disorders. Mechanistically, etifoxine and GRX-917 have been found to increase the production of neurosteroids, including allopregnanolone, an IV formulation of which was approved in the U.S. in 2019 for the treatment of postpartum depression. This mechanism of action is thought to underlie etifoxine's rapid onset of anxiolytic activity that is similar to that observed with benzodiazepines, but without the sedation, cognitive impairment, or abuse and dependence risks associated with this class of compounds. Further, etifoxine has an extensive safety database, which we believe will greatly de-risk the future development of GRX-917. Like etifoxine, we hypothesize that GRX-917 will provide rapid anxiolytic activity with improved tolerability compared to current treatments for anxiety, and the deuteration is intended to enable less frequent dosing and/or lower doses with GRX-917 than etifoxine. In June 2021, we initiated a randomized, double-blind, placebo-controlled phase I trial in Australia, which will ultimately enroll approximately 76 healthy adults. The study is a single ascending dose, multiple ascending dose design looking at safety and tolerability, pharmacokinetics, as well as pharmacodynamics using qEEG. Based upon the mechanism of action of GRX-917, we're using the qEEG as a target engagement biomarker, looking for increased relative spectral power in the beta band. Such changes have been demonstrated with IV allopregnanolone and related compounds and were also noted in a 2019 phase I trial of etifoxine that we conducted. Top-line data for the GRX-917 phase I trial are expected early in 2022. Moving to DemeRx IB, we are developing DMX-1002, an oral formulation of ibogaine, the latter a naturally occurring psychedelic product, as a potential disease-modifying treatment for opioid use disorder. We anticipate initiating the phase I component of an exploratory phase I/II-A trial of DMX-1002 in recreational drug users and healthy volunteers in the U.K. in the third quarter of 2021. To that end, we recently received approval from the U.K. Medicines and Healthcare products Regulatory Agency, or MHRA, to commence subject enrollment. The phase I/IIa trial is designed to assess safety, tolerability, pharmacokinetics, and efficacy, and the results will inform future studies in patients with opioid use disorder. We expect to obtain safety data from the phase I element of this trial in early 2022. We have an extensive early-stage pipeline that will be entering the clinic in 2022 and will provide a deeper update on these programs and associated milestones as we approach next year. It should be noted that the digital therapeutics being developed at IntroSpect are currently undergoing user acceptability testing at Kadima Clinic in San Diego. We anticipate rolling out the IntroSpect technology in our Viridia and Revixia phase I trials and DemeRx phase II trial starting next year. Finally, a brief mention of Compass Pathways and its compound COMP360, which is a proprietary formulation of synthetic psilocybin, a 5HT2A receptor agonist being developed as an oral rapid-acting antidepressant, is in order. In June 2021, Compass announced completion of dosing in the phase II-B clinical trial of COMP360 in a total of 233 patients diagnosed with TRD. This randomized double-blind dose ranging study investigating the safety and efficacy of psilocybin is the largest industry funded clinical trial of psilocybin conducted to date. Getting to this stage in this trial is a major achievement, and the Compass team should be commended for their incredible work. We look forward to the top-line data of this trial later this year. I will now turn over the call to Greg for an overview of our financial highlights. Thank you, Srini, and hello, everyone. As Florian mentioned, in June, we completed our upsized IPO of 17.25 million shares, raising gross proceeds of $259 million, including the full greenshoe exercise. Cash and equivalents totaled $453.6 million as of June 30, compared to $97.2 million as of December 31st, 2020. The six-month increase of $356.4 million is attributable to the IPO net proceeds of $231.6 million, plus $168.6 million from Series C and Series D common stock issuances, $20 million of licensed revenue proceeds, and $4 million proceeds from the sale of investments in conversion of convertible notes. Offsetting were cash payments of $32 million for investments in platform companies and $35.8 million in net operating expenses in the first half of 2021. Our operating use of cash for the six months ended June 30, 2021, was $14.6 million, which includes the positive effect of the $20 million in license revenue proceeds received from Perception Neuroscience's license and collaboration agreement with Otsuka Pharmaceutical. Operating costs and expenses in the first half of 2021 were as follows. Research and development expenses of $16 million and $21.6 million for the three and six months ended June 30, 2021, as compared to $2.9 million and $5 million for the same prior- year periods. The increase of $13.1 million and $16.6 million, respectively, were attributable to personnel costs, including stock-based compensation expense and increased CRO expenses related to advancements in our R&D programs. We also recorded acquisition of in-process R&D expense of $8 million and $9 million for the three and six months ended June 30, relating to our investments in Neuronasal and Inharris Bio. Moving to G&A expenses for the three and six months ended June 30, 2021, were $37.3 million and $46.6 million as compared to $2.9 million and $4.4 million in the same prior- year periods. The increases of $34.4 million and $42.2 million, respectively, were attributable to personnel costs, including stock-based comp expense, professional fees, and other costs related to support our platform growth and public company requirements. Total stock-based compensation expense for the three and six months ended June 30 was $37.5 million and $37.7 million, respectively, as compared to $41,000 and $82,000 for the comparable prior- year period. This reflects a recognition of expense related to the achievement of the IPO performance-based partial vesting conditions. The year-to-date R&D portion was $9 million and G&A portion was $28.7 million for your modeling. I'd like to draw your attention to two one-time items in our first half results. First, with Compass Pathways, where in the second quarter we booked a gain of $16.9 million relating to our investment in Compass May follow-on equity round. Atai participated and purchased 140,000 shares for $5 million, and we now own 19.4% of Compass. The licensing revenue of $19.9 million recorded from Perception's license and collaboration agreement with Otsuka Pharmaceutical. I'd compliment the management team at Perception, and everyone involved at Atai on this deal, and also point out that the strategic intent is to drive additional non-dilutive licensing transactions in the future. I'll now hand the call back to Florian. Thank you, Greg and Srini. I would like to thank the entire Atai team as well as our supportive investors and their contributions to all we've achieved this year. Looking ahead, we are energized to drive an important and catalyst-rich 2021 and 2022 with additional clinical readouts, trial initiations, and business development. This is an incredibly exciting time for Atai, and we will continue to provide updates on our program as they advance. Before we will take questions, I would like to highlight the following five key takeaways on our progress to date and roadmap forward. Number one, with our strong balance sheet and broad portfolio, we have solidified our leadership position as an innovative drug developer within mental health. Number two, by design, our company is structured to maximize the probability of success in drug development through a combination of basically three elements, a unique portfolio approach, a focus on developing compounds with prior evidence in humans, and a milestone-based approach to capital allocation. Number three, our differentiated model has been validated by our traction to date, where we are the only biopharma company developing psychedelics that has entered into a drug development collaboration with large pharma. Number four, Atai has accelerating momentum with 18 near-term catalysts, including phase II data readouts by year end from Recognify and Compass Pathways. Number five, we continue to drive our business development activities by incubating, acquiring, and investing in complementary compounds and enabling technologies. With that, we are happy to take questions Thank you, l adies and gentlemen, at this time, we will be conducting a question-and-answer session. If you'd like to ask a question, you may press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question. Yes, g ood morning, Florian and team. First of all, thanks for taking the question, and thanks for all the details in outlining the 12 and 18, call it, week and month plan. I had a quick question on RL-007, phase II-A in CIAS. I guess I'm wondering if you could provide a little bit more detail on the enrollment criteria regarding, call it, symptom presentation as well as concomitant medications, and perhaps frame a useful result for informing the next steps out of that study with regard to dosing and duration. Absolutely, Charles, thanks for the question. Generally speaking, of course, they have to meet the criteria of schizophrenia with a cognitive impairment that is, I believe, one sigma below normal. In terms of concomitant meds, they're allowed to have that. We are limiting it to aripiprazole and one other related compound, and that's really about it. Just to keep the population as homogeneous as possible. In terms of a meaningful outcome, as you'll recall, what we're trying to do here is extend the results of the previous phase I study, which was a scopolamine challenge study. In that trial, they found two things. First, they found improvements in verbal memory, they also found, concomitantly with that, changes in quantitative EEG. Specifically, they found alterations in the spectral profile, pre and post-drug. It was really shifting from lower frequencies to higher frequencies. Generally speaking, such higher frequencies are associated with improved cognition. Folks with schizophrenia, particularly those with prominent cognitive impairments, do have some degree of suppression of higher frequencies. They tend to run at lower frequencies. The very first thing that we're looking at is a replication of the quantitative EEG spectral shift. That's going to be the first thing. Then we'd like to extend from there to some of the evoked potential measures that we're looking at, mismatch negativity and P300. Broadly speaking, a win would be around some of the spectral shift. That's kind of the key here. Obviously, concomitant improvements in evoked potentials would be great, and we are doing cognitive assessments as well. Obviously, this is a very small study. We aren't expecting much, but if we find some proportionality of concordance with the EEG shifts, then that, of course, would be a big win as well. Okay, t hank you. One additional pipeline question, then a quick follow-up for Greg. Regarding the COMP360 results that could come towards the end of this year. We've spoken to Compass management about this, but we'd like to hear your perspective on what you'd like to see out of the trial in terms of, call it, three-week effect sizes and response rates, as well as longer-term durability, given that this is the largest controlled trial of psilocybin to date and given that it represents a new paradigm relative to the current standard of care. Okay, Charles, I think you said Greg, I'm willing to take that. Of course, Greg, if you want to chime in, please do so. With respect to the psilocybin study, clearly one of the things that we're looking at is the key, of course, is their primary endpoint at three weeks. That certainly shows a rapidity of onset, as well as some degree of durability. Of course, part of the promise of psilocybin is an extended duration of efficacy, of driving someone into remission. As such, we're certainly going to be watching the data from there on out, right? This trial does go out to 12 weeks post-dose. We'll be obviously looking at that. It's powered, certainly, for the primary endpoint of three weeks, and obviously these data will, of course, inform subsequent studies. Responder remission data over the subsequent weeks will be really quite key for understanding and interpreting the results from this trial. Does that answer your question? Okay, y eah. Yes, it does. It was for you. My follow-up for Greg was relative to OpEx over the course of, say, the 6-12 months. Not looking really for guidance, say, just a range. How do you see the income statement over the course of the next year or so? Yeah, t hanks, Charles. Greg here, g ood question. Inside the first half numbers, you've got some in-process R&D and a spike in the non-cash stock comp. If you strip it out, the OpEx in the first half is running about $18 a quarter. I think we're going to see personnel costs growing as we continue to support the platform companies and build out capabilities internally. As the pipeline moves to more clinical stage, we'll have just additional R&D spend is likely to grow there to support that activity as well. As a range, it'll be north of where we are now, in that maybe $25-$30 range per quarter as we go forward, would be directionally okay. That makes sense, t hank you for taking my questions. You bet, t hanks, Charles. Our next question comes from the line of Ritu Baral with TD Cowen. Please proceed with your question. Good morning, guys. Thanks for taking the question. My first question's on Perception Neuroscience and PCN-101. Can you review for us the dose and the dosing paradigm and treatment duration that you're using in the upcoming phase II-A that you plan to start in Q3? When we do get the data in 2022, I guess, what are the most important scales that we should be looking to for depression efficacy, but as well as the degree of dissociation, versus S-ketamine? Then I've got a follow-up. No problem, I'll start with that one then. In terms of dosing, we haven't really guided on that at this point. What I can say is that based on the phase I, we have some latitude on dosing, and we are certainly going with doses that are sub-dissociative based on the phase I results. That's essentially what we're doing there. In terms of endpoints, obviously the MADRS is going to be key here. You also talked about dosing frequency. This trial is a single dose. It's a single IV administration of the compound. Clearly, we're following the depressive symptomatology out to 14 days of primary to 24 hours consistent with other ketamine studies. The results of this trial will give us some indication of the dosing frequency or the re-dosing frequency, which we do anticipate will be required here, not unlike S-ketamine or ketamine proper. There's pre-clinical data suggesting greater durability of effect. That's really what's driving this hypothesis that we might be able to dose less frequently than S-ketamine, which, of course, is twice a week for four weeks. That's the long and short of it in terms of the dosing. In terms of endpoints, MADRS obviously is a key endpoint here. In terms of dissociative/psychedelic effects, there's really two things that we're focused on. Obviously, CDSS is something that's widely used in the industry, and we certainly are including that. I'd say that CDSS is perhaps not the best suited for this. We are also doing the 5D-ASC here. That'll give us a lot more granularity on the sort of psychedelic type effects that we're seeing with the compound. Got it, m y next question is on the DemeRx phase I/II study that you're planning on starting in Q3. Yep. Srini, you mentioned the safety in PK. Are you doing any special cardiovascular monitoring around the IV study? Again, since this is recreational drug users, what sort of efficacy data could you glean out of it, and when? Yeah, i n terms of cardiovascular safety, of course, there is a signal, depending on the publication for QT prolongation, in this population. I think there are some confounds with existing data. There were certainly multiple dosing experiments that had been done. The concentration of ibogaine wasn't necessarily clear, t hat's something that we're looking at very closely. We are doing Holter. We're doing repeated ECG endpoints as well in standard fashion here. We would like to see, of course, that there's a dose range that we can get to that is relatively devoid of QT prolongation. That's really the focus here. In terms of efficacy in the phase I element, the focus on the efficacy endpoints are really in the phase II piece, which is those individuals that are undergoing medically assisted detox. Looking at their withdrawal and then looking at long-term remission, if you will, is really what we're focusing on there rather than within the phase I component of the trial. Got it, t hanks for taking the questions. No problem. Our next question comes from the line of Brian Abrahams with RBC Capital Markets. Please proceed with your question. Hey, guys. Thank you so much for taking my questions, and congrats on all the progress. Maybe just starting with PCN-101, I was wondering if you could talk about the status of the subcutaneous formulation. You mentioned that would be moving into a bridging study in your opening comments. Just wondering, I guess, where that stands, what if any gating factors there are to starting that study, and what your target volume would be for that administration. I think a lot of that, the details here are not public. The long and short of it is that the formulation's under development, and of course, there's the formulation itself and then compatibility with the device, the subcutaneous injector. All that work is ongoing, t he BE study, as you're familiar, is relatively straightforward and very quick, right? It's basically comparative IV versus subcutaneous. As we mentioned in the opening remarks, we are looking to get the data from that contemporaneously, roughly with the other phase II results. That's ongoing currently. In terms of volume, the standard volume here for subcutaneous is keeping it under 2 mL. Obviously, we'd like to keep it significantly under 2 mL, and that's obviously what we're pursuing with our formulation. Great, thanks. You also have recently announced, Revixia launch to develop Salvinorin A. Just a couple of questions there. I guess first off, I'm curious on the digital therapeutic element there, which you talked about a little bit in your opening remarks and your vision for integrating that to help assist with dosing therapy and monitoring, how that might provide an administration advantage. Secondarily, you also pointed out that you don't interact with 5-HT2A which could potentially enable, I guess, additivity to SSRIs. I'm curious if you could also speak to how you envision the future program in terms of combination potential, both with SSRIs as well as with other TRD programs in your pipeline. Thanks. Yeah, I think that with Salvinorin, that's really the key point. I mean, clearly the compound is psychedelic. It has many properties in terms of the psychedelic experience that overlap with classical psychedelics, as well as with some aspects of ketamine as well. A very interesting compound. Certainly some, in this case, more anecdotal data around antidepressant efficacy. Very curious pharmacology overall. It's a kappa agonist. Many such kappa agonists, well, they tend to be a little more on the partial agonist side, like pentazocine and things that are related to that, but they tend to be more dysphoric. This is really quite an interesting compound. Because of its opioid receptor pharmacology, certainly the potential exists to be used concurrently with SSRIs, SNRIs, et cetera. That's what really is the value add here. Something that we're obviously very keen to pursue. More broadly, as we've discussed, clearly depression is multifactorial, and different patient populations may have different underlying pathophysiology driving that, including certainly in subsets aspects of opioid dysfunction. Perhaps this is better suited to that population. That's certainly why we're interested in this compound and pursuing it. In terms of the digital therapeutics, I mean, obviously this is a somewhat broader point. We've mentioned several times that the redose frequency is not necessarily clear from the outset, and it's going to vary undoubtedly by patient. Regardless of the compound, there'll be a subset that don't respond, there'll be a subset that have a very long-term remission. We envision the digital therapeutics not only to support the patient, both pre- and post-psychedelic in terms of pre-psychedelic, of course, pre-psychedelic administration, expectation setting and the preparatory work, and then post, providing a psychosocial therapy, not unlike a reSET-O from Pear. Also tracking symptoms and giving the treating physician input as to when the patient should be redosed. Again, this is more broad. This is certainly something that we're looking at with Viridia with its DMT program, as well as Revixia with its Salvinorin A program, as well as others. Does that answer your question? Yes, that's really helpful, t hanks, Srini. No problem. Our next question comes from the line of Judah Frommer with Credit Suisse. Please proceed with your question. Yeah, h i, thanks for taking the question. Maybe on a little bit more high level on this space as it kind of continues to evolve. I think that there probably are a couple narratives developing here where I think some companies in this space are assuming that we'll need a bit of a change in treatment landscape and maybe a real estate or treatment location change in terms of how patients are dosed with psychedelics. It does seem like your team is looking more to leverage the existing infrastructure in the mental health industry. Can you talk about thoughts about doing that as you move compounds through the clinic, and if there is any need to effectively reinvent the treatment landscape here? Yeah, I'll let Florian take part of that, g o ahead. Well, thanks. Happy to; a little around our thinking around that. We are certainly R&D focused, and that's our DNA and that's what we're doing right now is really focused on executing the trials. I think you correctly summarized that we intend to leverage the existing infrastructure that existed pre-J &J's approval with SPRAVATO, and that SPRAVATO or J&J is currently also building out to administer the inpatient SPRAVATO treatments. We intend to leverage the existing infrastructure and certainly observe and be closely involved in this ecosystem. Primarily focus on the development and execution of our drug development pipelines. I think there, and Srini can allude to how our therapies fit in what way in terms of treatment duration in a second. Here key for us is can be optimized. In general, the time of the therapist, especially also through the digital therapeutics that Srini already pointed out, as well as optimizing the duration of effect or the duration of the treatment in its entirety. Here really, slotting things into an existing infrastructure to really optimize for scale and to reach as many patients as possible in a thoughtful way. Srini, maybe you have some things to add, especially on kind of how to slot it into the existing infrastructure. Yeah, I think you hit upon the main points, right? The real question is scalability, and it's been mentioned a number of times by other players that there are limits to the number of therapists, et cetera, that one can train. Particularly, for those compounds that require a sitter, et cetera. The entire approach with both the Salvinorin A program, the DMT program, is to create an overall profile of psychedelic effect that mimics in some way S-ketamine. Really having something that has a psychedelic effect that lasts less than an hour. We're really targeting sort of the 30–45-minute range. Allows us to potentially leverage the S-ketamine infrastructure, and I believe J&J has over 3,000 clinics at this point. With such a short duration of action, our hypothesis, and it is that, is that we don't require the heavy lift of a traditional sitter in this context. That we'll find out relatively soon enough. Certainly, there's no real sitter, if you will, in the context of S-ketamine. We do believe that there is utility in supporting the patient, as I mentioned, both pre- and post the psychedelic effect, and of course, that requires therapy as well. If you have access to therapists, Godspeed, go for it. Certainly, the digital therapeutic is going to provide a baseline level of therapy and a standardized therapy, which I think will be quite beneficial. What we didn't get into is our work with Psyber, which is actually hardware. That hardware will provide aspects, if you will, of a digital guide. The idea here is really to get the patient into the appropriate mindset. These folks are very suggestible during the psychedelic effect, and you can kind of drive where things go with the appropriate discussion, where their minds are at prior to the psychedelic effect. Relaxing the patient may be beneficial. That's where the Psyber hardware is going to play an important role. Ultimately, again, hypothesis is that you can improve safety and potentially efficacy with digital therapeutics, though of course, with hardware-based digital therapeutics, feedback-based digital therapeutics. This is something that will be an active area of research for us. Okay, t hat's helpful. Thanks, t hen a quick follow-up on something I think we heard Greg say, tied to the Otsuka collaboration in terms of kind of pursuing additional non-dilutive financings as a strategy. Is that kind of a general comment? Is it tied specifically to PCN-101? Is it more tied to psychedelics and Big Pharma kind of validating the approach there? Just maybe a little bit more color on that comment. Sure, I think the Otsuka partnership indicates, I guess, a validation from our perspective of our ability to capture value. We have been executing for a while, but in March demonstrated also that we capture the value that we generated. It's one potential avenue and something that we want to build on, as Greg mentioned, and as you also pointed out. Here we intend as part of our strategy to continue the dialogue and potentially also enter into more agreements with strong strategic partners. That's kind of one avenue. Of course, we generally optimize for success, meaning that we get all our compounds to approval, especially given the broad set of enabling technologies that we have that are especially relevant for the psychedelic-assisted therapies that Srini just alluded to. Here we think we have a competitive advantage, and we'll nevertheless be very open and entrepreneurial when it comes to potential interest from other very strong strategic players. We'll always evaluate on a case-by-case basis to ensure we optimize here for shareholder value. Great, t hank you. Our next question comes from the line of Esther Hong with Berenberg Capital Markets. Please proceed with your question. Hi, good morning, and c ongratulations on all the progress. First question, wanted to ask about PCN-101, R-ketamine for TRD. Regarding dissociative effects or lack of, is there any difference in patients who may be more susceptible to potential dissociative effects, or is it pretty clear that it depends on dose strength, in this case, very high doses? I've got a follow-up, t hanks. That's a really interesting question. I think the short answer is we don't really know in terms of patient subsets. It's something that we're looking into. We have a couple of different avenues to be looking into that, including some of the digital aspects as well as some of the more metabolomic aspects. That's something that is of great interest. Right now, we're focused on dose, to be honest with you. Okay, got it. Wanted to ask about GRX-917, deuterated etifoxine for generalized anxiety disorder. Can you speak more about the non-deuterated etifoxine use in France? Specifically, the safety profile, where is it used in the treatment paradigm? Any additional details from its history of use in France? Thanks. Yeah, absolutely, t his is obviously a really old approval. This was approved in 1979 in France, and there were some sort of reciprocal approvals in other small territories, but nothing in any of the major territories. When it came out, it was viewed as a benzo light, but it was pretty obvious that its profile was quite different. At that time, in the late 1970s, early 1980s, this was kind of the heyday of benzodiazepines, and people attributed the sort of drunken feeling, if you will, of a benzodiazepine with efficacy. There was a bias against the compound right off the bat. It is something that has sold a significant amount that's used in particularly vulnerable patient populations, the elderly, et cetera, is where there's certainly been a lot of use. There was a publication a couple of years ago that spoke to the safety. This was from the safety database in France. I think it was about 13 million exposures and looking at overall safety. The compound's very well-tolerated, very limited effects in terms of reported adverse effects. Certainly, compared to other compounds, compared to benzo, it was quite clean. Even compared to SSRIs, the profile was very favorable. Specifically, no data suggesting that there's any kind of addictive properties or dependence issues with this compound. Got it, t hanks. Absolutely. Our next question comes from the line of Nathan Weinstein with Aegis Capital. Please proceed with your question. Good morning, everyone, and thanks so much for taking my question. Just a quick one on the pipeline for KUR-101. Would you consider a broader indication set beyond OUD, just given the range of traditional uses that the compound has had? Yeah, it's a good question. I tend to view opioid use disorder as kind of a spectrum. In many situations, particularly with iatrogenic opioid use disorder, it starts with the treatment of acute pain. It's interesting, there was a study that was done, a large cross-sectional study that suggested that 6% of patients that received a prescription for a acute opioid, in other words, a short duration opioid, if they took it, were still taking an opioid a year later. That's really kind of terrifying. Obviously things have clamped down significantly over the course of subsequent years. Regardless, there is a need for a compound that has a better tolerability profile than a traditional opioid. That is something that we're looking at. There's a spectrum from treatment of pain, both acutely and chronically, all the way to opioid use disorder, and that's something that we're going to be investigating with this compound. To your point, this is basically where kratom is currently used, right? If you look at the boards, as it were, like the Reddits and other places, as well as some of the publications, it really is used as a treatment for pain, particularly in those individuals that require more analgesia than non-scheduled compounds but can't tolerate an opioid. It's also used to mitigate withdrawal symptoms. That spectrum is what we're focusing on as we develop this compound. Great, t hanks. Just one follow-up, o bviously, one of the beautiful things about Atai is the multitude of different programs and the different APIs. Just curious whether the procurement of drug substance for any of the programs have been a logistical challenge or if you foresee it being so in the future. There have been no specific logistical challenge. Certainly a lot of ours are synthetic. There are three that are semi-synthetic or purified extracts, and that's ibogaine and deuterated mitragynine as well as Salvinorin A. We have good supply agreements for those products, so it hasn't really been an issue, and we don't anticipate it being an issue. In general, we'd like to minimize the amount of stuff that's coming from plants for a range of reasons, including environmental impacts. We are looking at alternative routes to producing the drug substance, but that's for a future discussion. Great, t hanks so much. There are no further questions in the queue. I'd like to hand the call back to management for closing remarks. Great, t hank you everyone for dialing in today and for all the questions that you had for us. Thanks also for everyone at the Atai team and all our investors that brought us here where we are today. I'm very looking forward to the future, what is yet to come. Very exciting times, w ith that, I would like to thank you all and wish you a very successful week. Thank you, everyone. Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.