Earnings Call: Q2 2021

Aug 16, 2021

Morning, and welcome to the Itay 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. Please go ahead. Thank you, and good morning. Welcome to our Q2 2021 Atai Life Sciences Financial results and corporate update conference call. The press release reporting our financial results is available on the Investors and Media section of our website at www. Tidot Life and our quarterly report on Form 10 Q ended June 30, 2021, will file today with the SEC. Joining me today are Florian Brand, our Co Founder and CEO Doctor. Srini Rao, our Co Founder and Chief Scientific Officer and Christian Shane Engelmyer, 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, Natalya'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 perspectives 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, and 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 Itay's CEO, Florian Brand. Florian? Good morning, everyone. Thank you all for joining our first earnings call following our successful completed IPO in NASDAQ in June, where we raised $259,000,000 We are thrilled by the enthusiastic response to our mission from the investor community, And we intend to use these proceeds to continue advancing our decentralized drug development platform in 2 ways: 1st, By executing on our existing pipeline and 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 And now it gives me great pleasure to introduce you to my visionary Co Founder Our Board Chairman, Christian Anamaylin. Christian? Thank you, everyone. With my co founders and the entire ATHI team, I share the common aim of I want to take a few moments to discuss Assai's origin and my commitment to Assai. 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 the time 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 Wilder, I hope you will leave this call with a real appreciation for both Applied's progress to date and what I hope will be an even brighter future to come. While I leave it to Florin 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 1,000,000,000 people globally Suffer from depression, addiction, PTSD, anxiety and other intractable mental health diseases. And that is just the official number. The unofficial one is most likely significant 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 US400 $1,000,000 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, As 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 and 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 3 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 Atay has the potential to become the leading mental health company globally, while building value for our shareholders and other 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, then Preeni will review highlights from our drug development pipeline, And Greg will provide the quarterly financial reports followed by the Q and A. For people not yet With our company, let me briefly give you an overview of Itai Life Sciences. We founded Itai 3 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. And these are all companies we have either acquired, controlling or 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 entire 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 perceptions licensing deal with Otsuka, an industry leader in innovative mental health therapies. This deal represents the 1st major partnership Biopharmaceutical Company Developing Psychedelic and Large Pharma. In only 3 years, we have aggressively built a pipeline of 11 development programs We believe that several of our target indications have a potential market opportunity of at least 1,000,000,000 in annual sales each once approved. Outside of our current focus indications, we see insignificant untapped 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 and D catalysts over the next 18 months, The result of our portfolio approach and our extensive pipeline. The 2 most imminent upcoming milestones are: First, COMPASS Pathways that is expected to provide top line results from their Phase 2b study in Q4 of this year. And second, RECOGNIFY Life Sciences that has initiated a Phase II trial and expect to have data by the end of the year. In addition, we plan to initiate Perceptions Phase II trial for TRD And Demerix Phase III OUD trial still in this quarter. Additionally, we plan to initiate 3 Phase II trials and 4 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 Ittai 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. The lead compound for Perception is TCN-one hundred and one, A formulation of Arketamine. Arketamine is a glutamatergic modulator being developed as a rapid acting antidepressant with non dissociated 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, rketamine has demonstrated higher potency, Greater durability and lower abuse potential compared to esketamine. The recently published results of an open label 7th subject trial in patients with treatment resistant depression, or TRD, using IV Arketamine supported the hypothesis that arketamine Maybe 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 products delivered at home. In February 2021, Perception announced positive Phase 1 results demonstrating the safety and tolerability of PCN-one hundred and one and 58 subjects treated at doses of up to 150 milligrams IV. The compound was well tolerated There were no serious adverse effects reported. Additionally, the pharmacokinetics of PCN-one hundred and one in plasma were found to be approximately dose proportional. Notably, the study demonstrated that PCN-one hundred and one required substantially higher doses to induce perceptual changes compared to esketamine. Importantly, we anticipate initiating our Phase IIa trial of PCN-one hundred and one in Q3 2021. This randomized double blind placebo controlled trial testing an IV formulation of arketamine 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 1 bioequivalence study to bridge from the IV formulation to a subcutaneous formulation of PCN-one hundred and one, one that we believe will support at home use. Next, Recognify Life Sciences is developing RL-seven, An orally available cholinergic, glutamatergic and GABA B receptor modulator. In aggregate, RL-seven'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 2a proof of mechanism study for RL-seven 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 R007 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-seven 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 7 on several evoked potential measures, including mismatched 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 IIa 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 matrix battery. Next, GABA Therapeutics' primary program is GRX-nine seventeen, an oral formulation of a deuterated version of edithoxine. The latter, a compound that has a long history of prescription use in France and other countries for treating anxiety disorders. Mechanistically, edafoxine and GRX-nine seventeen have been found to increase the production of neurosteroids, including alapregnanolone, An IV formulation of which was approved in the United States in 2019 for the treatment of postpartum depression. This mechanism of action is thought to underlie edifoxine's rapid onset of anxiolytic activity that is similar to that observed with Benzodiazepine, but without the sedation, cognitive impairment or abuse independence risks associated with these cost of compounds. Further, edafoxine has an extensive safety database, which we believe will greatly derisk the future development of GRX-nine seventeen. Like edafoxine, we hypothesized that GRX-nine seventeen will provide rapid anxiolytic activity with improved tolerability compared to current treatments for anxiety, And the due duration is intended to enable less frequent dosing and or lower doses with GRX-nine seventeen than ataboxine. 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-nine seventeen, we are using the QEG as a target engagement biomarker Looking for increased relative spectral power in the beta band, such changes have been demonstrated with IV alopregnanolone and related compounds And we're also noted in a 2019 Phase 1 trial of edifoxine that we conducted. Top line data for the GRX-nine seventeen Phase 1 Trial are expected early in 2022. Moving to Demerx IB, we are developing DMX 1,002, 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 1 component of an exploratory Phase onetwoa trial of DMX-one thousand and two in recreational drug users and healthy volunteers in the U. K. In the Q3 of 2021. To that end, we recently received approval from the UK Medicines and Healthcare Products Regulatory Agency, or MHRA, to commence subject enrollment. The Phase onetwoa 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 2020 2. We have an extensive early stage pipeline that will be entering the clinic in 2022, and we'll provide a deeper on these programs and associated milestones as we approach next year. Further, it should be noted that the digital therapeutics being developed at Introspect We are currently undergoing user acceptability testing at Academy and Clinic in San Diego. We anticipate rolling out the Introspect technology in our VrIDIA and and RAVYXIA Phase I trials and Demarex Phase II trial starting next year. Finally, a brief mention of COMPASS Pathways and its compound, COMP-three 60, which is a proprietary formulation of synthetic psilocybin, a 5 HT2A receptor agonist being developed as an oral rapid acting antidepressant is in order. In June 2021, Conference announced completion of dosing in the Phase 2b clinical trial of COM360 a total of 233 patients diagnosed with TRD, this randomized, double blind, dose ranging study investigating the safety and efficacy 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 17,250,000 shares, raising gross proceeds of $259,000,000 including the full green shoe Cash and equivalents totaled $453,600,000 as of June 30, compared to 97 $200,000 as of December 31, 2020. The 6 month increase of $356,400,000 is attributable to the IPO net proceeds of $231,600,000 plus $168,600,000 from Series C and Series D common stock issuances, $20,000,000 of license revenue proceeds and $4,000,000 proceeds from the sale of investments in conversion of convertible Offsetting were cash payments of $32,000,000 for investments in platform companies and $35,800,000 in net operating expenses in the first half 2021. So our operating use of cash for the 6 months ended June 30, 2021 was $14,600,000 which includes the positive effect of the Operating costs and expenses in the first half of twenty twenty one were as follows. Research and development expenses of $16,000,000 $21,600,000 for the 3 months ended June 30, 2021 as compared to $2,900,000 $5,000,000 for the same prior year period. The increase of $13,100,000 $16,600,000 respectively were attributable to personnel costs, including stock based compensation expense and increased CRO expenses related to advancements in our R and D programs. And we also recorded acquisition of in process R and D expense of $8,000,000 $9,000,000 for the 3 6 months ended 3 months ended June 30, 2021 were $37,300,000 $46,600,000 as compared to $2,900,000 $4,400,000 in the same prior year periods. The increases of $34,400,000 $42,200,000 respectively were attributable to personnel costs, Total stock based compensation expense for the 3 6 months ended June 30 was 37,500,000 respectively, as compared to $41,082,000 for the comparable prior year period. This reflects the recognition of expense related to the achievement of IPO performance based partial vesting conditions. The year to date R and D portion was $9,000,000 and G and A portion was 28 point I'd like to draw your attention to 2 one time items in our first half results. First with Compass Pathways, where in the Q2, we booked a gain of $16,900,000 relating to our Investment encompasses May follow on equity round. Pattai participated and purchased 140,000 And the licensing revenue of $19,900,000 recorded from Perception's license and collaboration agreement with Otsuka Pharmaceuticals. I'd compliment the management team at Perception and everyone involved at a tie 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 Thai team as well as our supportive investors in their contributions to all we've achieved this year. Looking ahead, we are energized to drive an important and catalyst rich 2021 2022 with additional clinical readouts, Trial initiations and business development. This is an incredibly exciting time for Ittai, and we will continue to provide updates Before we will take questions, I would like to highlight the following 5 key takeaways on our progress to date and roadmap forward. Number 1, with our strong balance sheet and broad portfolio, we have solidified our leadership position as an innovative developer within mental health. Number 2, by design, our company is structured to maximize the probability of success in drug development Through a combination of basically three elements, the unique portfolio approach, the focus on developing compounds with prior evidence in humans and a milestone based approach to capital allocation. Number 3, our differentiated model has been validated by our attraction to date, Where we are the only biopharma company developing psychedelics that has entered into a drug development collaboration with large pharma. Number 4, Ittai has accelerating momentum with 18 near term catalysts, including Phase 2 data readouts by year end from RECOGNIFY and COMPASS pathways. Number 5, 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. Ladies and gentlemen, at this time, we will be conducting a question and answer Our first question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question. Yes. Good morning, Florian and team. 1st of all, thanks for taking the question and thanks for all the details in outlining the 12 18, call it, week month So I had a quick question on RL-seven Phase 2a in CIIS. 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, and thanks the question. Generally speaking, of course, they have to meet the criteria of schizophrenia with a cognitive impairment That is, I believe, 1 sigma below normal. And in terms of Commented meds, I mean, there are a lot to have that. We are limiting it to aripiprazole and Just to keep the population as homogeneous as possible. In terms of a meaningful outcome, I mean, as you'll recall, what we're trying to do here is extend the results of the previous Phase 1 study, which is a scopolamine challenge study. And in that trial, they found 2 things. First, they found improvements In verbal memory and they also found concomitantly with that changes on quantitative EEG. Specifically, they found Alterations in the spectral profile pre and post drug and it was really shifting from lower frequencies to higher frequencies and generally speaking such higher Folks with schizophrenia, particularly those with prominent cognitive impairments, Do you have some degree of suppression of higher frequencies? They tend to be they tend to run at lower frequencies. So the very first I think that we're looking at is a replication of the quantitative EEG spectral shift. So that's going to be the first thing. And then we'd like to extend From there to some of the potential measures that we're looking at mismatch negativity in P300, I But broadly speaking, a win would be around some of the spectral shift. That's kind of the key here. Obviously, concomitant The improvements in Evoque 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. Thank 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, Clearly, 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 3 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, But I'm willing to take that. Of course, Greg, if you want to chime in, please do so. With respect To the psilocybin study, I mean clearly one of the things that we're looking at is the key of course is their primary endpoint at 3 weeks. That certainly shows the rapidity of Onset, as well as some degree of durability. Of course, With the promise, I mean 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. And so we'll be obviously looking at that. It's powered certainly to for the primary endpoint of 3 weeks and obviously These data will of course inform subsequent studies. I mean clearly responder data, 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? Yes, it does. And it was for you. My follow-up for Greg was relative to OpEx Over the course of, say, the 6 to 12 months, not looking really for guidance, but say, just a range, how do you see the income statement over the course of next year or so. Yes. Thanks, Charles. It's Greg here. So a good question because inside the first half numbers, You've got some in process R and D and some spike in the non cash stock comp. But if you strip it out, the OpEx in the first half Running about 18 a quarter. And I think we're going to see personnel costs growing as we continue to support the platform companies And build out the capabilities internally. And as the pipeline moves to more clinical stage, We'll have additional R and D spend likely to grow there to support that activity as well. As a range, it will be north of where we are now, Maybe 25 to 30 range per quarter as we go forward would be directionally okay. Our next question comes from the line of Ritu Baral with Cowen. Please proceed with your question. Good morning, guys. Thanks for taking the question. I have a my first question is on perception and 101. Can you review for us the dose and the dosing paradigm and treatment duration that you're using In the upcoming Phase IIa that you plan to start in Q3. And 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 disassociation Versus esketamine? And then I've got a follow-up. No problem. I'll start with that one then. So in In terms of dosing, we haven't really guided on that at this point. What I can say is that Based on the Phase 1, we have some latitude on dosing. And we are certainly going with doses that are So that's essentially what we're doing there. In terms of endpoints, obviously the MADRS is going to be kind of key here. You also talked about dosing frequency. So this trial is a single dose. It's a single IV administration of the compound. And clearly the results of the we're following the depressive symptomatology after 14 days of primary is at 24 hours with other ketamine studies. The results of this trial will give us some indication of the dosing frequency or the redosing frequency, which we do anticipate will be required here, not unlike esketamine or ketamine There is preclinical data suggesting greater durability of effect. So that's really what's driving this hypothesis that we might be able to dose less frequently than esketamine, which of course is twice a week So that's kind of the long and short of it in terms of the dosing. In terms of endpoints, mattress It's a key endpoint here. In terms of dissociativepsychedelic effects, there's really kind of there's really 2 things that we're focused on. Obviously, CAD is something that's widely used in the industry and we certainly are including that. I'd say that CAD is perhaps not the best suited for this. Are also doing the 5D ASC here. And that will give us a lot more granularity on the sort of psychedelic type effects That one may that we're seeing with the compound. Got it. And then my next Question is on the Demirex Phase III study that you're planning on starting in Q3. Srini, you mentioned the safety in PK. Are you doing any special cardiovascular monitoring around The IB study and then again since this is recreational drug users, what sort of Efficacy data, could you glean out of it and when? Yes. So in terms of cardiovascular safety, of course, there is a Signal, depending on the publication for QT prolongation in this population, I mean, I think there are some compounds with existing data. There were certainly multiple dosing experiments that had been done. The concentration of Ibogaine wasn't necessarily So that's something that we're looking at very closely. We are doing Holter. We're doing repeated ECG endpoints as well in We would like to see, of course, that there is a dose range that we can get to that is relatively devoid QT prolongation. So that's really the focus here. In terms of efficacy in the Phase 1 element, I mean, we are The focus on the efficacy endpoints are really in the Phase 2 piece, which is those individuals that are undergoing medically So, looking at their withdrawal and then looking at long term remission, if you will, is really what we're focusing on there rather than the Within the Phase 1 component of the trial. Got it. Thanks 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-one hundred and one, 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. I mean, the long and short of it is that the formulation is under development. And of course, there is the formulation itself and then compatibility with the device, subcutaneous injector, so all that work is ongoing. The BE study, as you're familiar, is relatively straightforward and very quick, right? I mean, It's basically comparative IV versus subcutaneous. And as we mentioned in the opening remarks, We are looking to get the data from that contemporaneously roughly with the Phase 2 results. So that's ongoing currently. In terms of volume, The standard volume here is for subcutaneous is keeping it under 2 milliliters. And obviously, we'd like Great. Thanks. And then you also have recently announced RAVYXIA launch to develop Sonoran A. And just a couple of questions there. I guess first off, I'm curious on the digital element there, which you talked about a little bit in your opening remarks and your vision for integrating that to help assist with dosing You don't interact with 5 HT2A, which could potentially enable, I guess, additivity to SSRI. So 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. Yes. I think that that's with Selvonor and that's really 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. So 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 CAP agonists, while they tend to be a little more on the partial agonist side like pentazacin and things that are related to that, but they tend to be more dysphoric. So this is Really quite an interesting compound. And because of its opioid receptor pharmacology, certainly the potential exists To be used concurrently with SSRIs, SNRIs, etcetera. So that's what really is kind of 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 is driving that, including certainly in subsets aspects of opioid dysfunction. So perhaps this is better suited to that population. So 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 mentioned several times that the redose frequency is not necessarily Don't respond. There will be a subset that have a very long term remission. And we envision the Digital Therapeutics Not only to support the patient, both pre and post psychedelic in terms of pre psychedelic, of Pre select or psychodilec administration expectation setting and the preparatory work and then post providing Psychosocial therapy, not unlike a RESET O from pair, but also tracking symptoms and giving the physician The treating physician input us to when the patient should be re dosed. And again, this is more broad. This is certainly something That we're looking at with VIRIDIA with the CMT program as well as RAVIXIA with its solvenorin A program as well as others. Our next question comes from the line of Judah Frommer with Credit Suisse. Please proceed with your question. Yes. Hi. Thanks for taking the question. Maybe want to a little bit more high level on this space as it kind of continues to evolve. I think 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 kind of 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 And if there is any need to effectively kind of reinvent the treatment landscape here? Yes, I'll let Troy take part of that. Go ahead. Yes. Well, thanks. Yes, happy to a little around hour thinking around that. So we are certainly R and D focused and that's our DNA and that's what we are doing right now is really focused on executing the trials. And in terms of how we and I think you correctly summarized that we intend to leverage the existing infrastructure That existed pre J and J's approval with SPRAVATO and that's SPRAVATO or J and J is currently also building out to administer the inpatient SPRAVATO treatments. So we intend to kind of to leverage the existing infrastructure and certainly kind of observe and be closely involved In kind of this ecosystem, but like primarily focus on the development and execution of our drug development Pipeline. And I think there and Tuni can allude to how our therapies fit in, in what way in terms of treatment duration In a second, but here key for us is can be optimized. In general, the time of the therapist, Especially also through the digital therapeutics that Sriniv already pointed out, as well as optimizing the duration of effect or The duration of the treatment in its entirety. So 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. And Srini, maybe you have some things to add, especially on kind of the how it's slotted into the existing infrastructure. Yes. I mean, I think you hit upon the main points, right? So the real question is scalability. And it's been mentioned a number of times that by other players that there are limits to the number of therapists, etcetera, that one can train, Particularly for those compounds require SITR, etcetera. So the entire approach with both The Salvator RNA program, the DMT program is to create an overall profile of psychedelic effect that mimics in some way esketamine. So really having something that has a psychedelic effect that lasts less than an hour, we're really targeting sort of the 30 to 45 minute range, Allows us to potentially leverage the esketamine infrastructure, and I believe they have J and 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. Of course, we will find out relatively soon enough. But certainly there is no real sitter, if you will, in the context of esketamine. So 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. And but 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 Cyber, which is actually hardware and that hardware will provide aspects, if you will, of a digital guide. So The idea here is really to get the patient into the appropriate mindset. I mean, 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. So Relaxing the patient may be beneficial. So that's where the cyber hardware is going to play an important role. Ultimately, Again, hypothesis is that you can improve safety and potentially efficacy with digital therapeutics. So of course, this is going to work with hardware Based digital therapeutics, feedback based digital therapeutics, but this is something that will be an active area of research for us. Okay. That's helpful. Thanks. And then 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 PCM-one hundred and To PCM-one hundred and one, 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 Exocrine partnership indicates, I guess, a validation from our perspective of our ability to capture value. So 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. So 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 therapy. As Srini just alluded to, here we think we have a competitive advantage and will nevertheless Be very open and entrepreneurial when it comes to potential interest from other very strong strategic players. So we'll always We evaluate on a case by case basis to ensure we optimize here for shareholder value. Great. Thank you. Our next question comes from the line of Esther Hong with Berenberg. Please proceed with your question. Hi, good morning and congratulations on all the progress. So first question, wanted to ask about PCN-one hundred and one, arketamine 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? And then, I've got a follow-up. Thanks. Yes, that's a really interesting question. I mean, I think the short answer is we don't really know in terms of patient subsets. Obviously, 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. So that's something that is of great interest. Right now, we are focused on dose, to be honest with you. Okay, got it. And then wanted to ask about GRX-nine seventeen deuterated edafoxine for generalized anxiety Can you speak more about the non deuterated edifoxine use in France and specifically the safety profile, where is it used So 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. And when it came out, it was viewed as a Benzolite, but it was pretty obvious that its profile was quite different. At that time in the late '70s, early '80s, this This is kind of the heyday of Benzodiazepines and people attributed the sort of drunken feeling, if you will, of Benzodiazepine with efficacy. So There was a bias against the compound right off the bat. And it is something that has sold a Significant amount that's used in particularly vulnerable patient populations, the elderly, etcetera, where there's certainly been a lot of use. And 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 13,000,000 exposures and looking at overall safety and the compound is very well tolerated, Very limited effects in terms of reported adverse effects. Certainly compared to other compounds, I mean 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. Thanks. 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-one hundred and one, would you consider a broader indication set beyond OUD, just given the range of traditional uses that the compound has had? Yes, it's a good question. So, I tend to view opioid use disorder as kind of a spectrum. And In many situations, particularly with iatrogenic opioid use disorder, it starts with the treatment of acute pain. And It's interesting, there was a study that was done, a large cross sectional study that suggested that 6% -ish of patients that received a prescription for Acute opioid, in other words, a short duration opioid, if they took it, we're still taking an opioid a year later. So that's really kind of Fine. And obviously, things have clamped down significantly over the course of subsequent years. But regardless, there is a need for a compound that Has a better tolerability profile than a traditional opioid. So that is something that we're looking at. Again, 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. And to your point, this is basically where Kratom is currently used, right? So if you look At the Boards as it were like the Reddit 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 And opioid, and it's also used to mitigate withdrawal symptoms. So that spectrum is what we're focusing on as we develop this compound. Great. Thanks. And just one follow-up. Obviously, one of the beautiful things about its high is the multitude of different programs and the different APIs. So just curious whether the procurement of drug substance for any of the programs had been a logistical challenge or if you foresee it being so in the future? I mean, there have been no specific logistical challenge. I mean, certainly a lot of ours are synthetic. There are 3 that are Semi synthetic or purified extracts and that's Ibogaine and deuterated metryaginine as well as salvinorin 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. We are in general, we'd like to minimize the amount of stuff that's coming from plants for a range of reasons, including environmental impacts. So we are looking at alternative routes to producing the drug substance, That's something that will be that's for our future discussion. There are no further questions in the queue. I'd like to hand the call back to management for closing remarks. Great. Thank you everyone for dialing in today and for all the questions that you have for us. Thanks also for everyone at the entire team and all our investors that brought us here where we are today. And I'm very, very looking forward to the future, what is yet to come, Very exciting times. And with that, I would like to thank you all and wish you a very successful week. Thank you, everyone.