Cybin Inc. (HELP) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Cybin's Conference Call and webcast. [Operator Instructions] I would also like to remind everyone that this conference call is being recorded today, Wednesday, March 13, 2024, at 8:30 a.m. Eastern Time. I will now turn the call over to Cybin's Chief Executive Officer, Doug Drysdale. Mr. Drysdale, please go ahead.

Thank you, Todd. Good morning, everyone, and thank you for taking the time to join our call today. We have some incredibly exciting updates to share with you today about our lead program, CYB003, our proprietary deuterated psilocybin analog in development for the adjunctive treatment of major depressive disorder, or MDD. And while I'll speak more depth later about the importance of the word adjunctive here, I want to point out that CYB003 is the only psychedelic development as an adjunctive therapy for MDD, which is a key differentiator. Before we begin, please take a moment to note the caution statement language on Slide 2 and also on our website. This morning, we announced 2 very meaningful achievements. First, CYB003 received breakthrough therapy designation from the FDA. And second, our 4-month Phase II durability data showed a sustained reduction in depression symptoms at the 4-month mark, after just 2 doses of CYB003. Notably, this is the first known breakthrough therapy designation by the FDA for an adjunctive psychedelic-based therapy the treatment of MDD. Following my introductory remarks, our Chief Medical Officer, Dr. Amir Inamdar, will walk you through the outstanding data in great detail, and share our vision for the path forward in light of having been granted BTD. What you'll hear from Amir about our Phase II durability data is truly remarkable. At 4 months, participants experienced a sustained reduction and incremental improvement in depression symptoms. With the mean reduction from baseline in the MADRS total score of approximately 22 points compared to a mean reduction of 14 points versus placebo and 17 points from baseline at 3 weeks. This is highly encouraging, especially for patients who have not responded to existing treatment options. The benefits of breakthrough therapy designation are numerous. It provides an expedited review pathway as well as increased access to FDA guidance on trial design with the potential to significantly reduce drug development timelines. The designation acknowledges the urgent unmet medical need for more effective treatment of MDD and support CYB003's potential for significant improvements over existing therapies. Breakthrough therapy designation serves as validation of our progress to date. And looking ahead, we can see a clear path through MDA submission. This is truly remarkable. These 2 milestones both reflect and drive Cybin's rapid progress and serve to advance the broader psychedelic sector. Importantly, the durability data we are sharing today confirm our earlier findings and make us even more confident in our ability to continue the rapid pace of clinical development and to deliver more effective treatments to address what can only be described as a mental health care crisis today. Before we get into the details on CYB003, I'll first share an overview of the company and provide some context around this inflection point, including how we see Cybin leading the way forward, and revolutionizing the treatment landscape for multiple mental health disorders. For those of you who may be new to Cybin story, we are a clinical-stage biopharmaceutical company with a straightforward mission to create safe and effective psychedelic 2.0 therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions. To support this goal, have an accomplished team of drug development experts supported by a network of world-class partners and internationally recognized scientists who share our goals. We are applying deuteration to each of our programs, optimizing pharmacokinetics without adversely affecting the underlying pharmacology, all with the goal of delivering fast onsetting effects and a shortening time in the clinic. Intermittent dosing versus existing chronic daily treatments and convenient dose forms, including oral and intramuscular. Importantly, rapid and sustained therapeutic effects with positive safety legacy. Our experienced leadership and scientific teams have a proven track record of bringing multiple drugs to market, and having collectively manage 60 INDs with the FDA. Cybin has a large intellectual property portfolio in the psychedelic drug development sector with over 50 patents granted and more than 170 patents pending. We have the industry's most advanced and well protected deuterated DMT program and 2 proprietary advanced clinical programs in development for depression and anxiety disorders, each now with proven and demonstrated safety and efficacy in Phase II studies. During the past few months, we have made enormous strides and have critical near-term value-driving catalysts across our leading programs. First, we plan to initiate the Phase II study of CYB004 in generalized anxiety disorder, or GAD, in the next few weeks with the top line data readout around the end of this year. And second, we intend to commence our Phase III study of CYB003 in MDD around midyear 2024. And just to reiterate the strength of our team and the depth of our collective real-world experience, this slide illustrates the deep-rooted psychedelic, pharmacal regulatory and academic research expertise behind our programs. The global mental health crisis, and yes, it is a crisis, and it cannot be ignored. The numbers today are nothing short of staggering and this is what drives our commitment to developing safe, effective and patient-friendly treatment options to bring relief to those suffering. Let me share just a few chilling statistics. Almost 1 billion people globally suffer from a mental health disorder with 280 million people world wise suffering from depression. Notably, after 30% of people with depression do not respond to traditional antidepressant treatments. And the risk of suicide is 20x higher for an individual with depression compared to a person without it. Today, SSRIs are the most common first-line pharmacologic treatment for depression, even though up to 2/3 of patients do not remit with this initial antidepressant therapies. Additionally, antidepressants often have dose-limiting adverse effects, including weight gain, sexual dysfunction, GI disturbances and insomnia. And as you're going to see, with each successive line of therapy, efficacy goes down, intolerance goes up and the chance of relapse increases. When compared with existing therapies, including SSRIs, CYB003, the turquoise column here has shown significantly greater improvements. Note the CYB003 effect for 12 milligrams and 60 milligrams pooled after a single dose. A 14-point reduction in MADRS depression scores compared to over 200 SSRI studies, delivering on average around just 2 points reduction versus placebo. These CYB003 efficacy and durability results also outpaced other psychedelic Phase II results that we have seen. As I mentioned upfront, CYB003 is the only psychedelic being developed as an adjunctive treatment for MDD. This is really important for several reasons. First and foremost, patients do not have to titrate of their background medications, which is a significant benefit to them. The titration process can be both challenging and nonlinear as some patients experience withdrawal symptoms, which can be severe after years of antidepressant use. It also eliminates logistical hurdles and the potential anxiety caused by the prospect of having go off and on to medication, even if that medication has not been pretty effective on its own. And as you can see, current approved adjunctive medications for MDD offer minimal incremental benefit when compared to the magnitude of effects being with CYB003. The treatment patent data show that 18% of MDD patients take multiple antidepressants, 51% take 1 antidepressant and 31 don't take any at all. Keep in mind, many patients have been on antidepressants for multiple years. If they are not getting the desired response from that medication, they might be eager to try something else. So CYB003 will target roughly 70% of the market with patients currently taking 1 or more background medications. Now is the time for a paradigm shift in metal health care and Cybin has the scientific drug development expertise and commitment to lead the way to new, safe and effective options. Before I turn it over to Amir, I'll just highlight the full picture of our advancing pipeline. We are proud of how quickly we've advanced the programs to date and look forward to sharing our progress in coming months. In addition to the rapid headway we're making on CYB003, I'd like to quickly touch on the advancements we're making with CYB004. Imagine with a simple IM administration as simple as a flu shot, we can potentially deliver a 90-minute experience with CYB004. And this is quite compelling, especially when compared with the other long-acting psychedelic development for GAD. And we expect to have top line data readout for CYB004 by year-end. Today, though, our focus is on showcasing 2 critical milestones that we achieved quickly and efficiently. I'll now turn the call over to Amir to walk you through the impressive findings and implications for our next steps. Amir?

Thank you, Doug, and good morning, everyone. Really excited here to provide you with an update on 2 pivotal milestones in our development program for CYB003. As Doug mentioned, the FDA has granted breakthrough therapy designation of BTD to CYB003 as an adjunctive treatment in patients with MDD. We are beyond excited about this opportunity to be able to bring this ground breaking treatment to patients as soon as possible. Now this BTV highlights 2 very important things: first, that the current treatments for MDD are suboptimal. And there is a significant unmet need for new treatments that act faster, are more efficacious, do not need to be taken daily, are not associated with dose-limiting side effects as seen with current treatments, and provide long-lasting efficacy. Second, it acknowledges the significance of our results and the potential for CYB003 to demonstrate an advantage of currently available treatment thus addressing the unmet need that I highlighted above. This, of course, significantly derisks our program and provides us with distinct advantages that will allow us to fast track the development of CYB003. It gives us access to a rolling review of the MDA with the FDA, the ability to work under FDA guidance for our clinical development plan, and ultimately, be able to benefit from priority review and accelerated approval. Our Phase I, II study design has been previously communicated. But very briefly, this study was designed to evaluate safety and efficacy of CYB003 in healthy volunteers and in patient with MDD in a double-blind randomized placebo-controlled design. This was conducted in participants aged 21 to 65 years old. In cohorts 1 to 3, we assessed pharmacokinetic and safety, and we identified a dose that with strong psychedelic effects could be seen. Each participant received 2 administrations of the study drug. Patients with MDD that were enrolled in the study were at least moderately depressed and we confirm the diagnosis using the MGH free for interview and they had to school at least 21 on the [indiscernible] as the depression rating scale or the MADRS, which one assessed by remote and independent rate. MDD Patients we enrolled in the study were inadequate responses, which meant that they had failed to respond to the current antidepressant treatment. But in [indiscernible] has not treatment [indiscernible] patients, and we allow patients in this study to remain on a stable dose of their antidepressant medication. As Doug referred to earlier, about 70% of patients are on some form of treatment earlier for MDD and developing CYB003 as an adjunctive therefore, addresses an unmet need for a large proportion of these MDD patients. Within each MDD cohort, after screening, which lasted up to 4 weeks, participants were randomized to refuse [indiscernible] enacted placebo with a minus 2 to 3 ratio, respectively. During the study participants have provided psychological support by facilitator who were trained in our EMBARK protocol. After being discharged from the clinical unit on day 1 after the dosing, participants came back into clinic to receive a second dose 3 weeks later where the primary efficacy of a single dose of CYB003 was assessed as an improvement in symptoms of depression using the MADRS and comparing this to the placebo patients. All participants, including those who received a placebo at baseline came back to receive a second dose after -- a second active dose after 3 weeks and the same protocol as for the first dose was followed for the second dose also. We conducted the second assessment for incremental efficacy 3 weeks after the second dose. So this was a day 42 of week 6. We also had an absolute period of assessment of [ work ] 2 months after the second dose to help us determine the durability of treatment effects, and I'll share these data with you today. On this slide, you will see that the populations enrolled across the 6 cohorts with comparable in terms of their baseline characteristics. Most of them were in the 30s and 40s, there's fairly balance in terms of males to females and had an average baseline MADRS score for MDD patient, which place them into a moderate-to-severe depressed category. And this despite being on an antidepressant medication, which we believe is representative of a large proportion of the MDD population. We previously shared our top line data after a single dose of CYB003 but to basically summarize, a single dose of 12 milligrams of CYB003 resulted in a rapid and large reduction in symptoms of depression. At the 3-week primary endpoint, CYB003 was better than placebo to about 14 points with a highly statistically significant p-value of 0.0001. This translated into an effect size of more than 2, which will appreciated as a very large effect size. Similar large and robust effects were also seen with a single dose of 16 milligrams, which resulted in an improvement in symptoms of depression as measured using the MADRS total score again by about 13 points when you compared it to placebo. Again, these results were highly statically significant and the effect size was more than 2. We have also previously shared our rationale to administer 2 doses instead of 1 and our hypothesis by the second dose of CYB003 would result in additional improvements in symptoms of that, it will ensure benefits are sustained for a long period of time, and this has now been validated. So both the 12 and the 16-milligram dose with the second administration of CYB003 at 3 weeks, not only was the initial response to a single dose sustained up to the 6-week time points but it also resulted in an incremental benefit over and above the effect seen at 3 weeks by approximately 6 points in the MADRS total score. We also have data from facilitator debriefs. These were the people who [ track ] with the patients in the room when they were receiving the drug. And these debriefs have told from the second resulted in a more intense and a more immersive experience than the first dose. And in some ways, the first dose appear to have prepared the patients to benefit fully from the second dose. Again, evaluating our hypothesis of 2 doses. This is also evident when we measure our response and remission rates. As a reminder, the response conventionally is defined as a 50% or more improvement in symptoms and remission is defined as a MADRS score of 10 or less. We will dose of CYB003 about 50% of the participants responded. And about 20% of the participants went into remission and this was not only sustained but became even better at 6 weeks. At the 6-week assessment, more than 75% of the participants responded and almost 80% went into remission with the 12-milligram dose. That is 8 out of 10 patients were no longer depressed by 6 weeks with just 2 administration for CYB003 three weeks apart. And that's not all. It gets even better. And I'm pleased to share with you now the results from our follow-up that has recently completed. At the 4-month follow-up, this incredible improvement in symptoms was sustained for both the 12 and the 16-milligram doses [ have seen ] on this as well. On average, the reduction in MADRS score strong base line to about 22 points in each of these dose out and this was after 2 doses of CYB003. Of note, no psychological support provided during the full study follow-up period, which is after the 6-week endpoint and no psychotherapy was administered during any part of the study. As you will recall, patients randomized to placebo baseline received an active second dose. These patients had also followed up to 4-month time line. What we saw was that these placebo patients who received an active second dose also maintained their improvement in symptoms, all these the magnitude of improvement was smaller when compared to patients receiving 2 doses of CYB003. Again, clearly supporting our hypothesis of 2 doses that we included in this protocol. As we will also undoubtedly note the line almost flat towards the end, which means that if you follow the trajectory, one could speculate that these improvements would persist for at least several more weeks, indicating that the durable effects lasting up to 6 months can reasonably expected after just 2 doses of CYB003. This is even more remarkable when you actually look at the response and remission rates, using the same definitions of response and remission as previously. For both the 12 and the 16-milligram doses, response rates continue to be maintained through to 4 months after the second half with about 3/4 or 75% of the patients still maintaining their response. Similarly, in terms of remission 60% of patients at 12 milligram and 75% at 16 milligrams were in remission or no longer depressed 4 months after 2 doses. As I pointed out on the previous slide, looking at trajectories of response, it may be reasonable to speculate that this trend could be maintained at, at least up to 6 months. All of this in the background of a favorable safety profile. We now have safety data out to the 4 months -- 4-month end point after the 2 doses, and it still remains compelling with a relatively benign side effect profile. We did not have any serious adverse events and all adverse events that were reported in the study was mild-to-moderate intensity. We saw no evidence of increased suicidality after treatment with CYB003. And only the think cases of nausea, vomiting, which are also observed in the placebo group. Any increases in the heart rate or blood pressure with transient, and there was no effect on EKG or any of the laboratory parameters. So in summary, and I am sure you will agree, this is incredibly positive news for CYB003 in particular and for patients with MDD in general. We saw rapid improvement in symptoms after just a single dose of CYB003 and improvement in symptoms are not just rapid but also large and clinically significant see as to 14 points difference from placebo, an improvement in the MADRS total scores. These results were highly statistically significant with large effect sizes, far superior than what has been traditionally reported with antidepressant treatments. We also validated our approach of administering 2 doses. As we saw an incremental benefit of a second dose by approximately 6 points in the MADRS and more than 75% in response and remission rates with 12 milligrams after 2 doses. Equally importantly, we demonstrated that these results are not transient but durable of 4 months with 60% of patients at 12 mgs and 75% at 16 mgs still in remission without requiring any further treatment with CYB003. All of this is the background of an excellent safety and tolerability profile with only mild-to-moderate adverse effects and more responses to psychedelic. And to top it all, we have recently had our end of Phase II meeting with the FDA and have lined ourselves on the Phase III program, which we intend to get going imminently. We shall be providing more details regarding this at a later date. I am extremely excited and invigorated with these development with positive efficacy data demonstrating durable effects up to at least 4 months after the second dose breakthrough therapy designation and alignment with the FDA on our Phase III plans. We are poised to deliver a life changing treatment to people who are desperately waiting. With that, I'll pass over to Doug for some concluding remarks.

Thank you, Amir. I think you'll agree, everyone with me that what you've heard this morning is truly outstanding. We now have a clear and compelling data that showed that CYB003 to be an acute adjunctive therapy with the potential to deliver durable remission and provide a clear clinical benefit. We are highly focused and have a lot of work to do, and we look forward to towards a new drug application. We expect to initiate our Phase III MDD trial around mid-year 2024, having aligned with the FDA on trial design. 15 sites, all trained and experienced in running psychedelic trials have already been selected in the U.S. and European sites will be added. Our clinical suppliers have been manufactured and are ready for the trial to commence. [indiscernible] by now, 2024 shaping up to be a breakout year for our programs. We're just weeks away from starting our Phase II study of CYB004 in generalized anxiety disorder with top line data expected in the fourth quarter. And as you've heard, we expect to begin our Phase III multisite global trial of CYB003 in MDD around midyear, and we promised to share more details on the trial design in due course. We now have important clarity on the path forward for our therapeutics. To the combination of breakthrough therapy designation and the compelling durability data shared today for CYB003 validate our approach and offer great promise. I'm grateful for the support of our many stakeholders and as always, the tireless efforts of the Cybin team members, all of whom are deeply committed developing differentiated next-generation therapeutics with the potential to improve clinical outcomes and address key unmet needs for people with mental health conditions. I'll now open up the call for questions.

[Operator Instructions] Our first question comes from Charles Duncan with Cantor Fitzgerald.

This is [indiscernible] on for Charles Duncan. So the response rates were largely comparable from day 42 to 4 months. But could you help us understand the larger shift in remission rate when comparing the 12 mg and the 16 mg doses at 4 months at day 42, it's superior with the 12 mg, and we thought it was due to better tolerability potentially. But we're trying to understand how the 16 mg being the higher dose drives that increase in remission at 4 month?

Amir, do you want to take that?

I can take that -- yes, I can take that one. So I think first thing, we have to bear in mind is the numbers, it's a small data set. So you can see a range of results there. Tolerability wise, we actually did not see any significant difference between 12 and the 16 milligrams doses. We initially thought actually to stop at 12 milligrams but we decided to go up to 16 only because not everybody is 12 milligrams [ dose responders ] in clinical practice and we wanted to have an option to be able to push the dose up in some patients. And therefore, we pushed it up to 16 milligrams to see whether there are any issues with tolerability and we found that, it's comparable between the 12- and the 16-milligram dose. And even though you see some differences in the remission rates between 12 and 16. They, I think, are largely due to the [indiscernible] we've got almost twice the number of patients that we have with 16. So I wouldn't worry too much about it.

Okay. As a quick follow-on, will you look at both 12 mg and 16 mg in the Phase III?

We are going to share details of our Phase III design at the later date. As I mentioned earlier, we have had our discussion with FDA, we have aligned on, which doses trends to move ahead with. All I can tell you now, it's one of those 2 doses.

Yes, I think it's fair to say that we're going to move forward with the 16-milligram dose that was in discussion with FDA.

Our next question comes from Sumant Kulkarni with Canaccord Genuity.

I have two. The first one, if you look at the 12 mg and the 16 mg doses over time, they seem to be around the same at the furthest standpoint but what do you think it means for subsequent doses? Do you think you might need to go even higher than 16 mgs on a fresh dose once a patient has another episode of depression?

Thanks, Sumant. Yes. I mean, currently, the belief is no, we don't believe we need to go beyond 16 milligrams if a patient requires subsequent dosing. As you know, we had 2 doses at -- one at day 21 -- first dose at day 21 and the second at day 42. There is some incremental benefit of that second dose in terms of absolute change in the MADRS, that's small about 6 points. It's, of course, twice, what you see with SSRIs or SNRIs but the real utility of the second dose is in maintaining that response. Importantly, the dose of 16 milligrams or even 12 milligrams in patients results in a full psychedelic experience or peak psychedelic experience or what we call it a full mystical experience. And I know the data that has been published very recently as well about the relationship between achieving a full mystical or psychedelic experience and the therapeutic efficacy. So both of those levels in patients achieved a full mystical experience or full psychedelic experience. So I don't believe we will need to go beyond 16 at all for therapeutic efficacy.

Got it. And then did you see any changes in background uses. I think the present standard of care in the patients in this trial as you progress from week 3 to 6 to further endpoints? And how do you expect to ensure consistency around this variable if it matters during a Phase III program?

Yes. So we -- in the 4 months follow-up, we have actually not collected those data but we are looking at options to get those data and analyze whether people -- and how people complied with the ongoing antidepressant medication. The instruction to be towards you have to scale a stable dose of antidepressant throughout the study. So we would expect that the state on the stable doses of antidepressant. In the long run, this is something that we will watch out very carefully in our Phase III studies. Our Phase III studies will be much longer, especially in the long-term follow-up will be much longer in line with the FDA guidance, and we will include specific forms in the study where we collect usage of -- data on usage of antidepressant. [ If you may ] not be unreasonable to avail that if a patient is feeling better or in remission, let's say, 6 months down the line, then we tempted to stop their antidepressant medication. Patients get better, they stop the medication. That's good when [indiscernible] but we will collect those data and when those are available, we will share.

Our next question will come from Patrick Trucchio with H.C. Wainwright.

Congrats on this data. I have a couple of follow-up questions. So first, I'm wondering if there are any learnings to emerge from the study regarding the patients who appear more likely to respond initially and then maintain that remission over time. Secondly, I'm wondering if you can discuss more specifically the product profile you see emerging for CYB003 based on this data and assuming you're able to replicate the positive results in Phase III? And then lastly, I'm wondering if you can talk about the role of psychological support in the Phase II trial and how you envision this support in the Phase III protocol, and how you would envision that support in a potential commercialization of CYB003 in clinical practice?

Maybe I'll take the follow-up question and hand rest over to Amir. So I think that's a good question. As Amir mentioned, we saw -- we've seen robust durability data out to 4 months. And those lines look pretty flat. You can't see any real regression back to baseline at that time point. So it's reasonable to assume that we may continue to see benefits in past 6 months. Our view is -- and we've had some discussions with FDA around this that beyond 6 months, they might consider another episode of depression as an acute episode -- another acute episode rather than a relapse retreatment. And that's interesting, I think, from a development perspective in terms of streamlining studies and reducing safety database. So we could see this as a 2-dose regimen for an episodic depression perhaps 6 monthly or so and as an adjunctive treatment to MDD. In terms of patients that have responded and not responded, I think that's quite difficult to pull that information from this study size. We obviously have along the larger sample size in Phase III. I will say that it appears that when patients respond, they really respond, the changes are quite large. So clearly, there's a group that is not responding, a very small group here but we'll have more info on that in Phase III. Amir, maybe you want to comment on psychological support?

Yes. Yes. And very quickly on responders. As Doug said, the characteristics -- the only [indiscernible] people who respond is that they have a pretty intense experience and a pretty immersive experience, which we kind of ensure by giving a second dose. First dose acting as a prep for the patient, for the experience in the second dose, they are able to fully experience the immersive nature of these psychedelic effects. And you see that in incremental benefits over time. But going back to the question about psychological support, we used -- it's -- the standard clinical framework, which is basically when people enroll into this study before they receive any medication in the 3-dose period, they were provided with psychological support, which largely consisted of psychologic patient what to expect from the treatment. And the sort of rapport building with the patients, which is not unlike any other treatment. Most of it will be remotely, we'll utilize telemedicine quite a bit in this study to deliver the psychological support element. The only time there is an actual requirement for the -- monitor what facilitators providing psychological support to be [indiscernible] patients during the dosing session and that's largely and only reassurance, nothing else. And then post treatment, again, in the post-dose period, they were provided with debriefing sessions. We expect to use the same approach in Phase III program. What we've done was we've made that psychological support program, which is called EMBARK and develop in-house, we streamlined that a bit more. As we've into a program called EMBARK CT or EMBARK for clinical trials, which basically is aimed towards scaling -- helping scale that psychological support to the large Phase III clinical trials, which will be [indiscernible] the patient. So fundamentally, nothing changes in the psychological support program except that we've streamlined it for a later phase.

[Operator Instructions] We'll go next to Jim Molloy with Alliance Global Partners.

This is Matt Venezia on for Jim Molloy. First of all, congrats on the data readout. My first question was, are you guys planning at all to include patients -- that 30% of patients of MDD who are not on an SSRI? I know in the last R&D Day that you had talked about only patients that are already on an SSRI for the Phase III but will you be including the 30% at all down the road as like a monotherapy?

Right now, the indication is for exemptive. We are only designing studies with CYB003 and adjunctive to ongoing antidepressant SSRI or SNRI. Maybe once we've completed this adjunctive program, there may be an opportunity to explore CYB003 as monotherapy as well but the current indication in the plan is as an adjunctive to SSRIs or antidepressant.

Yes. I'll add to that, that clearly, this is unlikely, we think, in the current sort of environment for de novo patients that are not on any background treatment just to jump straight to a psychedelic treatment. It's more likely that they'll go through their primary care physician, receive a few tries of SSRIs or SSNRIs before making it to a specialist, and that's where we see these treatments being positioned. So might be interesting to study patients on their medications but it seems in the real world that, that's an unlikely scenario.

Got it. So just a follow-up. You guys mainly see the second dose being prescribed by specialists exclusively?

Yes.

Okay. Got it. And then I just wanted to ask a little bit about the small pharma assets and how the clinical development for those is going currently?

Yes, sure. Thanks for asking that question. Obviously, we're very excited about these CYB003 results but also excited about CYB004. We will be achieved with the small pharma combination, which has gone very smoothly and very efficiently. We combined our various data sets, a total of 5 trials now around deuterated DMT. A lot of Phase I PK/PD data that really helps us understand the dosing dynamics of DMT and deuterated DMT. And of course, we also have Phase II results from non-deuterated DMT in depression and the impact on anxiety scores. So we have a terrific proof-of-concept and [indiscernible] side of the small pharma, the work was all adjacent nonoverlapping and has enabled us to jump right into a Phase II study with CYB004 and move from an intravenous infusion to a simple intramuscular injection, just like a flu shot. And that was possible because of the combination of the data sets and of course, importantly, the combination of all of the collected IP between the 2 companies. So we are focused on CYB004 now and moving into Phase II that IND has been cleared by FDA for intramuscular study. And we're just a few weeks away here from taking [indiscernible].

Our next question will come from François Brisebois with Oppenheimer.

Can you guys hear me okay? Sorry, I've been having issues at the [indiscernible]. So just how do you guys -- just can you touch on the commercial potential here? And just thoughts around duration. It seems like the angle has been to do maybe a shorter duration treatment even with 003. Now it seems like repeat dose is probably the angle you're taking. I'm just trying to understand if 004 is a 90-minute kind of procedure, how does 003 look in terms of duration? And any thoughts about the scalability aspect of the commercial side for a shorter duration here versus a longer duration?

Yes. I think duration is important, but so is the protocol and the redosing time line and schedule. It's encouraging now to see Spravato doing very well. I think it's J&J's fastest-growing product at this point. And that's for the treatment that requires patients to go to a clinic for treatment 8x in the first 4 weeks and then multiple times thereafter. So 8 visits to the clinic, they have to be driven back by a third party because they can't drive afterwards, not going to drive for the rest of the day. So basically, those days are short for [indiscernible] so 8 of those visits in 4 weeks. We see here with both CYB003 and CYB004, much reduced overall time lines and a dosing schedule, at least with CYB003 here. There might be 2 visits at a minimum every 6 months or maybe longer. So a far less onerous and burdensome scheduled and protocol for the patient. As we've said before, with CYB003, we see a very rapid onset of effects because of the pharmacokinetics we've modified effects begin in about 15 minutes than the [indiscernible] at about an hour. The peak psychedelic effects last about 2 hours. So that's really the therapeutic window, that's to our point. and then patients come down into the sort of tail of the PK curve, like and then a bit of an optic of it. So on average, we allowed the patients to sit as long as they wanted in the Phase II trial. And facilitate as you said judgments on when the patients were ready to go. But on average these sessions lasted 4 to 6 hours, something like that. So a little shorter than anybody expects with traditional [indiscernible], which is around 6 to 8 hours and certainly a lot shorter than you might see with the long-acting psychedelic like LSD.

Have you guys done work on kind of the health economics to these clinics and the centers, and the benefits of shorter acting or more patients in the chairs. Any work there on the commercial front yet?

Yes, we have done some initial work. And our initial view was that once you start to see durability beyond about 8 weeks or so, so fairly short, economically, the starts that are very interesting for payers. And of course, now we have durability data out to 4 months or so. We're continuing to do work with payers. We're going to primary research, and we will share some of those thoughts on the other day.

We do have a follow-up question from Sumant Kulkarni with Canaccord.

A couple. First, as an organization from a commercial point of view, what do you think the sweet spot is for durability of your treatment? And second, when do you expect to have meeting minutes for the end of Phase II meeting from the FDA in hand? And in broad strokes, can you give us any details on what the FDA was most focused on during that meeting?

So the -- our goal has always been from the outset to maximize durability. That's why we went with the 2-dose regimen in the study. We've hypothesized that would be more intense second experience that the efficacy results would be sustained for longer. And in our own hypothesis and the discussions with FDA, we are trying to aim for a point of at least 6 months before retreatment and also aiming for a label that is acute treatment of a depressive upside of MDD rather than having to establish a sort of more personalized redosing schedule. And of course, when you have -- the more acute label than the safety required -- database requirements are reduced as well. So that's part of our ongoing thinking as we look to repeat some of this data in Phase III. And then in terms of FDA discussion, I can say that it was a very collaborative meeting. We had more than 20 or so folks from FDA participate. There seems to be a very wide interest across all departments in FDA in these treatments and learning about them, very collaborative discussion [indiscernible] to our Phase III proposal that are no surprises. I would say we are -- we have a clear path to Phase III and no hurdles now, we believe, to beginning the first study around midyear.

At this time, I would like to turn the call back to Mr. Drysdale for any additional or closing remarks.

Yes. Thank you, Todd. So that concludes our call today. Thank you all for your interest in Cybin and for joining the call. And we look forward to doing this all again to CYB004 in a matter of months. So thanks very much for joining. Have a great day.

This does conclude Cybin's conference call and webcast. You may disconnect your line at this time, and have a wonderful day.