Cybin Inc. (CYBN) on Q2 2022 Results - Earnings Call Transcript
Operator: Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to Cybin's Second Quarter Fiscal Year 2022 Earnings Call. At this time, all participants are in a listen-only mode. Following the prepared remarks, we will conduct a question-and-answer session open to financial analysts. Instructions will be provided at that time for you to queue up for your questions. I would also like to remind everyone that this conference call is being recorded today, Monday, November the 15, 2021 at 4:30 p.m. Eastern Time. I will now turn the call over to Cybin's Vice President of Investor Relations, Leah Gibson. Ms. Gibson, please go ahead.
Leah Gibson: Thank you Nadia, and welcome to Cybin's second quarter conference call. This is Leah Gibson, Vice President of Investor Relations for Cybin. With me on today's call is Doug Drysdale, Chief Executive Officer of Cybin and we will also be joined by our COO, Aaron Bartlone; Chief R&D Officer Mike Palfreyman; CFO, Greg Cavers and Co-Founder, Executive Chairman and President, Eric So for the Q&A session following Doug's remarks. Before we get started today, I would like to remind everyone that certain statements made on today's call relating to the company are forward-looking statements and our perspective in nature, and preparing these forward-looking statements several assumptions were made by Cybin and there are risks that actual results obtained by the company will differ materially from those statements. As a result, the company cannot guarantee that any forward-looking statement will materialize and you are cautioned not to place undue reliance on them. Cybin refers current and potential investors to the forward-looking information sections of its management's discussion and analysis available@sedar.com and on edgar@sec.gov. Forward-looking statements represent Cybin's expectations as of November 15, 2021. Except for that which is required by securities laws, Cybin does not undertake any obligation to update any forward-looking statement, but as a result of new information, future events or otherwise. With that, I'll turn the call over to Doug.
Doug Drysdale: Thanks Leah. Good afternoon, everyone. And thank you for joining our business update call today. The past 12 months has been a period of rapid scientific exploration and progress for us. And we're thrilled to share our - accomplishments with you today. At Cybin, we're on a mission to transform psychedelics into therapeutics. The need for safe and effective mental health treatments has never been greater. The pandemic has exacerbated the mental health crisis around the world. We are dedicated to researching and developing, transformative psychedelic therapeutics to improve treatments for all those who suffer. To achieve this, we have assembled a team comprised of world-class scientists, industry leaders, and external partners so that together, we can push the boundaries. We are taking what we already know about classical psychedelics and engineering them with the goal of creating safe, effective and commercially viable therapeutics for all those in need. We have evolved since our founding into a leading company in the psychedelic industry, because we have and continue to evolve our entire ecosystem. By this, I mean we are focused on engineering, proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches, and treatment regimens for mental health disorders. I'll describe these in more detail in a few moments. Over the past 12 months, we have intentionally built out an ecosystem to optimize psilocybin therapy, always with patients in mind. We are working hard to create an infrastructure to support the scientific exploration and push the boundaries. Let me touch on some of our recent achievements. To-date, we have developed a portfolio of over 15 novel compounds and have expanded our intellectual property to 15 patent filings across three patent families. This is a major differentiator for the company and we anticipate that we will continue to add to our patent portfolio in 2022. Additionally, we have completed 74, preclinical studies supporting the advancement of CYB003 and CYB004 toward clinical development, showing key dosing and bioavailability advantages over classical psychedelic molecules with significant progress made in drug preparation with our partners. First in human studies are expected to begin in early 2022, subject to receivable of all necessary approvals. As a company, we have grown from five employees to 55 and now have a presence in Canada, the U.S., U.K. and Ireland and we are extremely proud of the fact that we are the first and only company in this sector to be listed on the New York Stock Exchange. Partnerships are also critical to accomplishing our goals and in the past year, we have established 50 such partnerships with world-class scientists and advisors and clinical research organizations. Just recently, the U.S. Drug Enforcement Agency granted us a Schedule I manufacturing license for our Boston Area Research Lab, allowing us to expand our internal research and development capabilities. And more recently, we received FDA authorization for our sponsored first of its kind feasibility study using Kernel's quantitative neuroimaging technology, Kernel Flow to evaluate ketamine effect on brain hemodynamics using a wearable headgear device. We hope that this may allow for quantification of brain activity during a psychedelic experience. We also launched the EMBARK Psychedelic Facilitator Training Program in collaboration with the University of Washington in preparation for the first clinical trial of psilocybin-assisted psychotherapy. We are cosponsoring the study with addresses COVID-19-related distress in frontline healthcare professionals. We're awaiting final approval in order to begin to initiate this study imminently. We're passionate about helping these healthcare workers many of whom have suffered tremendously in caring for those gravely ill with COVID-19. And we created our EMBARK Psychedelic program to support both therapists and patients. And lastly, we recommend - we recently welcomed Dr. Amir Inamdar as Chief Medical Officer, Dr. Geoff Varty as Head of Research and Development; and Leah Gibson as Vice President of Investor Relations. The Cybin team has done an extraordinary job advancing our promising approaches to developing safe and effective therapeutics for patients with mental health disorders. Today, I'd also like to share the meaningful advances we are making in our preclinical programs, notably, CYB003. Our comparative preclinical data shows multiple potential advantages over classical psychedelic molecules, which we believe may have wide reaching implications for the treatment of mental health. This work is especially urgent today, as nearly 700 million people globally are affected by some form of depression, addiction or eating disorder according to the World Health Organization. Some estimates indicate that anxiety disorders affect up to 12% of the U.S. population and that's why we're so committed to what we do. Turning now to our drug development programs, we have made important scientific progress thus far and continue to add to that progress every day. In order to improve on existing therapeutics, we had to identify the challenges of the molecule itself, so that we can address them. There is no doubt that academic studies and a recent Phase II study have shown efficacy with psilocybin. Yet our goal is to transform these molecules into potentially useful and practical therapeutics that may ultimately receive regulatory approval, and with the aim of improving the safety profile and treatment protocols to benefit providers, payers, and most importantly patients. We have had three parallel programs working on psilocybin for the past 12 months, two programs CYB001 and CYB002 looked at formulation approaches. And the third is built around our proprietary psilocybin analog CYB003. The goal of course is to identify the best candidate at the lowest cost to take forward into clinical studies. All of this work is centered-around addressing the known challenges or psilocybin as a therapeutic. And these limitations include three issues; one, high variability in plasma levels, which means the potential for unpredictable patient outcomes, adverse events and side effects. Two, slow time to onset, meaning patients often have to wait up to an hour and a half to achieve peak effects. And three, long duration of treatment, with some patients experiencing eight-hour clinic days, resulting in limited scalability due to the increased time and resource burdens on payers, patients and providers. We at Cybin believe that we can do better and we're aiming to do so. We've learned a great deal through our extensive work on CYB001 and CYB002. In the case of CYB001, we selected a lead formulation prototype and made study supplies. But the psilocybin release from the sublingual film was still greater than 10 minutes, resulting in the potential for more than all over these profiles than a sublingual release profile. CYB002, on the other hand is a fast dissolving oral formulation designed to improve the rate of psilocybin release. And while the dispersion occurred in just seconds, so vast improvement, the oral nature of the formulation would still result in a long duration of action. As you can see, we've taken different approaches to try to overcome some of the challenges of psilocybin and to optimize where we make our development investments which, brings us to CYB003 our proprietary deuterated psilocybin analog with improved properties and in our view, Cybin's strongest candidate with which to move forward. We believe that we have a positive obligation from a patient perspective and in terms of delivering value to shareholders to advance only the most promising programs with the most efficient use of capital. CYB003 has been designed with the goal of achieving better patient outcomes, including less variability in plasma levels, faster onset of action, shorter duration of effect, and better brain penetration. We conducted many studies in multiple species with models of psychedelic action, studying pharmacokinetic profiling, and following FDA safety requirements for the eventual advancement towards clinical use. All of this was done in order to predict a safe and efficacious human dose. What we found was that CYB003 has the potential to offer three main benefits. One, patient clinic days that are cut in half, as a result of 50% reduction in both time to onset and total duration of treatment with CYB003, compared to oral psilocybin, providing for potentially greater access and scalability for providers and payers and patients, two, approximately half the dose of oral psilocybin to achieve psychedelic effects, due to almost two times brain penetration. This could result in less drug in the peripheral circulation, and the potential for reduce side effects such as nausea and headaches, which are commonly seen with psilocybin. And three, more predictable patient responses due to a 50%, reduction in variability compared to oral psilocybin, resulting in a safer therapeutic profile, and a potential for reduced serious adverse events. All in all, CYB003 has been designed with the aim to retain all of the therapeutic potential of all psilocybin while cutting the duration, and the potential for negative effects in half. Importantly, and for the reasons I shared a few minutes ago, we also see this as an opportunity to combine MDD and AUD that is major depressive disorder and alcohol use disorder into a single program with patent protection from a family of nine file patents. That lends itself to cost savings and efficiencies, and we believe has the greatest potential to deliver positive outcomes for patients. As the next steps with the program, we believe we have built a highly capable, internal scientific team and have procured the external partnerships necessary to rapidly advance CYB003 through development. Our plan is to complete the full array of 32 preclinical studies by quarter one, 2022. Also in quarter one, 2022 we anticipate completing Chemistry, Manufacturing and Control or CMC development, including the production of clinical materials. IND or Investigational New Drug and CTA, or Clinical Trial Application filings are expected to be made with the U.S. FDA and the U.K., MHRA respectively, in quarter two of 2022. Then early-phase clinical trials leveraging our innovative EMBARK psychotherapy program are expected to subsequently commence in the U.S. and the U.K., following regulatory approvals that quarter. We are very excited by these findings, and are well prepared to advance to CYB003 program through these development phases, subject to receiving all the necessary approvals, and we look forward to keeping you apprised on our progress. The psychedelics industry is rightfully garnering a lot of attention for the groundbreaking work that is underway. The success of last week's Wonderland Conference in Miami is indicative of the promise and the passion in our industry and I believe we all came out of that conference even more confident that as an industry we can research potentially safe, effective and accessible psychedelic treatments to patients. We believe it is strongly supported by our expectations for CYB003, as well as a look into the first clinical data that is being reported on oral psilocybin from one of our peers. We welcome and are excited about the advancements being made in our industry, yet we are also aware of the improvements that still need to be achieved to involve psychedelics into therapeutics, and that's why we are so excited about the potential of CYB003. Turning now to our financials as of September 30, 2021, our cash and cash equivalents totaled $75.2 million. Our net loss was $17.6 million for the quarter ended September 30, 2021, of which non-cash expenses totaled $6 million and cash base operating expenses totaled $11.6 million. Thank you for your time and attention today, as we continue to experience the lingering effects of the COVID-19 pandemic. It's absolutely urgent that we work to address the devastating impacts of mental health disorders in an ethical and safe way, I'm proud of all that Cybin has accomplished towards this end. And I'm optimistic about our ability to move the needle and work towards researching and developing safer, more effective treatments so all of you can benefit. We'll now open up the call for questions from our analysts on the line. Thank you. Operator?
Operator: And our first question today comes from Charles Duncan of Cantor Fitzgerald. Charles, please go ahead. Your line is open.
Charles Duncan: Super, thanks good afternoon Doug and team. Thanks for taking our question. And congratulations on the good progress recently. I had a couple of questions about the recent data that came out of Compass. And I guess I'm wondering, you know, you've described a target product profile that looks pretty compelling. But the data came after your design of CYB003. So as you parse the recent data release, and I know it hasn't been presented yet? But if you consider that data and think about not only a next in class, but perhaps best-in-class profile, as you've described with 003. What gives you confidence in terms of the preclinical profile that 003 can really fit the bill? And are there any particular observations in that recent data that make you really intrigued with the profile of 003?
Doug Drysdale: Hey thanks, Charles, appreciate the question it's good to hear from you. You're absolutely right about the data that came from the Compass 60 study was compelling, but not real surprises I have to say and that we've known a lot about psilocybin for quite some time. And so, we've known and thought that it had great - essential for efficacy, but with some limitations. And I think the study confirms that it confirms that psilocybin is clearly effective in depression, and I think that's good for all of us. But when we look through the data, I think there is, a number of things that are confirmatory of our strategy with CYB003. The first is when you look at side effects, about 30% of patients in the study, experience nausea or headache. We've known this about psilocybin for some time. And we're hopeful that and ability to dose half of the drug level with CYB003 mildly to a reduction in those side effects. We saw and I think this was noted much and that perhaps some concerning serious adverse events, including suicidality or self-injury. And while those may be associated with the patient group, there's also potential that it could be associated with the wide around wide degree of variability that are seen in plasma levels with psilocybin. And so, the ability to reduce that variability significantly at least, if nothing else goes a long way, I think to try to address some of those potential serious adverse events. And then I think that the third aspect from the study is when we look at the data, I've seen these comments that perhaps the durability of the factor is not as robust as some are expected. And that may mean a need for repeat dosing, and may not be a one dose and done, it may be that patients need two doses or three doses. And we will see as we get through more clinical studies, but one thing we do know is that if repeat dosing is necessary, then having less time in the clinic half the time in the clinic is certainly more conducive to that kind of dosing regimen. So, I think that we'll be seeing from the data is really encouraging. I think it gives us great confidence in terms of efficacy, and what we're seeing in the probability of CYB003 is an improved pharmacokinetic profile. And the good news is that pharmacokinetic profile that we've taken through multiple species. We believe have high confidence will translate directly into a similar PK profile in that. Thanks for your question Charles.
Charles Duncan: Yes, that's super. One quick question in terms of this path forward, and then and add on in terms of IP. With regard to CYB003 given the target profile that you mentioned and given the data that you've seen out of Com 60 program, as you think about the path forward? Would you imagine it to be capital efficient and perhaps more capital efficient, than perhaps you would have assumed maybe even a week or so ago especially given the profile of 003, and an ability to move quickly from first demand studies to efficacy to registration?
Doug Drysdale: Yes, I think in terms of drug development, we couldn't be in a better place. And that's the core of the molecule for analog psilocybin has just been shown to be efficacious in a Phase II study so what a great place to be starting from. Often that is – overhanging and there's a rush to proof-of-concept. We're fortunate that we can optimize - we can want to optimize the molecule. So I think we can move quickly now, once we get through the IND process, to some quick PK studies to confirm the PK profile, and then quickly into dose escalation studies in patients with MDD. I think it gives us a fairly rapid path to later proof-of-concept . And then you had a question about the…?
Charles Duncan: Yes, just quickly Doug an appreciate you taken all the questions. It seems like well, pretty interesting that you could deuterate a compound and get rapid absorption and less variability. And so my question is, do you think that you're able to make non-obvious observations about the profile that could result in new chemical entity type IP?
Doug Drysdale: Yes, we definitely think that this molecule is a new chemical entity. So far, we filed nine patents in this family around the substituent space and so we expect some strong protection and more patents to add to that. I will say that the deuteration provides quite a lot of benefits in addition to creating some metabolic stability, which helps to remove some of that variability. Deuteration also significantly enhances oral bioavailability and helps improve brain penetration. So all those factors contribute to the lower dosing and the quick onset of CYB003 as you said.
Charles Duncan: Appreciate the added color, I'll hop back in the queue.
Doug Drysdale: Thanks Charles.
Operator: Thank you. Our next question comes from Sumant Kulkarni of Canaccord. Sumant, please go ahead. Your line is open.
Sumant Kulkarni: Good afternoon, thanks for taking my questions. First, it's a clarification question. Is there anything else that needs to be gleaned out in preclinical trials before you can say that you're 100% taking 03 into clinical trials or had that decision already been made?
Doug Drysdale: Hi, Sumant it's good to hear from you. Yes, we're confident at this point that CYB003 is our lead candidate to move to clinical studies. We have about 10 preclinical studies that are ongoing to be completed materials in place and CROs in place. So we're coping around the timing, we expect to complete those in the first quarter. And then we do an IND filing shortly thereafter.
Sumant Kulkarni: Good to hear that. So - any preclinical comparisons that you could make on the intensity of the psychedelic effect of 03 versus oral - psilocybin and how that might translate to a therapeutic effect in clinical?
Doug Drysdale: That's a question beyond my technical capability. I'm seeing Mike Palfreyman is on the line Mike are you available to answer the question about animal models of psychedelic action? I think, I think we're missing Mike Sumant. So maybe we can take it offline and we can follow up from there and look into clinical studies that we performed.
Sumant Kulkarni: Sure. And then have a last one, given that 03 is a new chemical entity and will require, you know the full clinical trial pathway, any kind of comments you could make on spending outlook behind that?
Greg Cavers: I will say that, Oh, go ahead Doug…
Doug Drysdale: No, I will say that, as we've combined MDD and AUD under a single program, then that leads itself to efficiencies. We don't know precisely at the regulators what the total safety exposure numbers will be, but clearly by combining two indications under one molecule that's ultimately going to lead to some savings. I'm also hopeful and expectant that as we move through the program. We will be taking advantage of every opportunity we can to accelerate development through breakthrough therapy, designation or fast track designation and other jurisdictions, that of course ultimately leads to faster, more efficient development. So, I do think that the combining the programs and the nature of these programs leads to fairly efficient drug development will depend to some product dose given.
Sumant Kulkarni: Got it, thank you.
Mike Palfreyman: Doug, this is Mike Palfreyman and I apologize, I had a technical challenge to answer the question with regard to comparison between psilocybin and the CYB003 on its potential psychedelic properties, and therefore therapeutic properties. There is an animal model that one can use in mice, and there you can compare the efficacy of both compounds, and then relate that to the blood levels of the compound. And that model has been shown to be translational, in the sense that it correlates well with psychedelic response to what you would see in humans for a variety of different psychedelics. And that data has confirmed that the efficacy is similar meaning it's got the same peak height, but the dose response is in favor of the more active compound in terms of its pharmacokinetic properties being more suitable, as we've described for therapeutic benefits. So again, it's an animal model, but it is known to correlate with a clinical response.
Sumant Kulkarni: Thank you.
Doug Drysdale: Thanks.
Operator: Perfect. Our next question comes from Patrick Trucchio of H.C. Wainwright. Patrick, please go ahead. Your line is open.
Patrick Trucchio: Thanks good evening, I have a few questions. I guess the first follow up question I have is just based on, you know, if everything goes to plan, when would you expect to have the Phase I data reported? And to what extent would you expect the animal data you've generated states translate to humans in a Phase I trial? Just in terms of the potential points of differentiation you pointed out versus other psilocybin like compounds?
Doug Drysdale: Patrick, thanks for the questions. I think in terms of the Phase I data reporting, assuming we start to dose around the end of the second quarter of next year. I expect that will have to be dosing data, so PK and escalating those data around the end of 2021, early 2022, most likely, so fairly quickly. And in terms of the animal data, I think one thing that's really unique about the situation that we're in, is that you'd be waiting on proof-of-concept to sort of confirm efficacy, which is the hardest thing to translate right in from animal models into men in CNS and psychiatric disorders. Here, we have that sort of analogous data in recent Phase II study. So what we're looking for is to translate pharmacokinetic properties, which we've already seen that are consistent, consistent patent across three species already. So we're pretty confident that will translate into men.
Patrick Trucchio: Yes, that's helpful. And then just based on preclinical data that's been generated to-date do you have an idea of what doses you could evaluate in CYB003 clinical development program? And would you anticipate perhaps having a cohort in the Phase II portion that may evaluate multiple doses of CYB003, perhaps spread one or two weeks apart along with the single dose cohorts?
Doug Drysdale: Great questions, so right now, we haven't decided the final range of doses that we will study we'll note that down in the very near future here. But it's likely from the - preclinical data that we've seen, that the dose of CYB003 is around the half of what you'd see with psilocybin and that's the range and of course, that's the possible range we'll have to test that range obviously, if you go through the doses escalation study. Sorry what was your second question, Patrick.
Patrick Trucchio: Just in terms of, you know, maybe having a cohort with multiple doses, in addition to having a single dose?
Doug Drysdale: Oh yes, we think that's useful to investigate that and as we're looking at Phase II designs, that's certainly something that we'll be contemplating. And one of the benefits of having the recent Phase II data out there as we've got some kind of leading indicators of what to expect. And so our team is already evaluating the potential for looking at multiple doses, I think makes a lot of sense, yes.
Patrick Trucchio: Yes, yes I agree. And then just one last one, just clarification on the IND to be filed should we anticipate that the program, the way it will be design would be for CYB003, would this be a study the trial design would it be a Phase I/IIa design that maybe or maybe you can move seamlessly from healthy volunteers into subjects in the Phase IIa portion or would it be, would these be completely separate and I guess what are the advantages of maybe combining it in that way.
Doug Drysdale: Yes, you're absolutely right and some of the benefits of working in two jurisdictions with the U.S. and the U.K. is that we built a supply chain in both jurisdictions, enabling us to work in parallel without having to ship Schedule I product across the Atlantic. And then how that enables us to work both in the U.S. is necessary for FDA, but also take advantage of some of the regulations in the U.K. though a little easier. So it doesn't mean that we can potentially create a nested study like that and move through healthy volunteers into MDD patients fairly seamlessly you're correct.
Patrick Trucchio: Perfect thank you very much.
Doug Drysdale: Thanks, Patrick.
Operator: Thank you. Our next question comes from Francois Brisebois of Oppenheimer. Francois, please go ahead. Your line is open.
Francois Brisebois: Hey, thanks for taking the questions. I was just wondering maybe a difference between recent data from another company. Can you just help us understand why the choice of MDD versus TRD and maybe expectations there in terms of the placebo effect and the treatment effect in MDD versus TRD?
Doug Drysdale: Hi Franc, thanks for the question. We've been committed to MDD from the beginning and it's more of clinical trial strategies, then maybe ultimate also at use. But as we think about the least risky path to proof-of-concept MDD patients I think provide that whereas some TRD patients might be quite resistant to any kind of therapy. And I think there is a bit of a misunderstanding or sometimes differential understanding of what TRD really is. And in some cases, these patients are those that have just tried two or three SSIs and maybe they tolerate them. In other cases, it may be patients that really have tried many treatments and don’t have an effect in the resistant to treatment. So there is a difference I think between try multiple doses and B3 resistance. Either way, I think, to start out the first proof-of-concept efficacy study with the most resistant patients doesn't make a lot of sense. So we're starting with MDD, it's a larger population. We've seen, if you look at the STAR D study and other studies of SSRIs that, SSRIs is going to be not much better than placebo over the long-term in patients with mild-to-moderate depression. So this is a large population of patients, that need good help and that's the way we will start. Then there is always an option to look at TRD somewhere down the line as got through the proof-of-concept.
Francois Brisebois: Okay.
Doug Drysdale: In terms of the people, you're right, I mean and sorry second question if that's okay. In terms of placebo, you're right, there is a placebo effect at every depression study and we've been working to evaluate how that’s the drop side. Some of that comes from study design, but some of it also comes from the tools so that we used to screen patients and we've been working with a group at Med General Harvard Medical School in designing and using a tool that is a secondary screen. So once the patients have been recruited by the investigator screened by the investigating team, the second group an arm's length basis would perform a further screen to make sure that absolutely patients they get into the study. I think that's just an extra kind of belt and suspenders to make sure we've got the right patients and doing it right.
Francois Brisebois: Okay, that's very helpful. And just on that note, on the placebo note, I think the placebo arm in these trials as those very interesting. Is it fair to assume that because you might be able to get similar efficacy, if not better with a lower dose. Can you share any thoughts that you might have on the placebo arm, would there be a danger of using a 1 milligram dose of the psilocybin analog if the efficacy might be larger here?
Doug Drysdale: So the placebo debate is a significant one with our scientific group and it's one of the major questions that we expect will have for regulators as we go into those pre-IND or scientific advisory meetings in the first quarter of next year. I think that's important to get their views on. I think one benefit of CYB003 opposed to CYB001 is that we can potentially use a low dose I am not saying its 1 milligram there might be something lower than 0.5 milligram, which was challenging with CYB001 because of the formulation, but that's certainly a potential that will evaluate along with other options try to pursue that.
Francois Brisebois: Okay. And then if I could sneak just a last one and there's just a lot of interest in the field right now, on the scalability front potential advantages with a quicker acting treatment. Are you mostly trying to have an advantage on the scalability side based on the administration or is there with the EMBARK program is there potential for scalability advantages on the prep and the integration phases of the psychotherapy?
Doug Drysdale: Yes, I think the challenges to scalability are multiple fold and the first is one challenge might be this adoption by clinic, at the end of the day, these treatments have to be administered somewhere in a clinical setting and the supervision. And if you can't get depression clinics and physician clinics to adopt treatments because they are actually burdensome and patients can't access. Another aspect is reimbursement is the supporting care around the molecule is too expensive, a eight-hour session then there is a hurdle there to reimbursement, which might limit access for some patients. So it's really about ensuring patient access. The EMBARK program is what we're doing there is making that program open source for therapist we want to make sure that therapists are trained if they want to be trained in the EMBARK program and have access to the tools so it's combining the clinical networks with the training program and the molecule, bringing those together and it's a formula and infrastructure an ecosystem that can support patients.
Francois Brisebois: Okay, that's it from me. Thank you very much.
Doug Drysdale: Thank you, Franc.
Operator: Thank you. Our next question comes from Andrew Partheniou of Stifel. Andrew, please go ahead. Your line is open.
Andrew Partheniou: Hi, good evening. Thank you for taking my questions maybe first starting off with your with your CYB003 program for your IND or CTA applications could you walk us through how that's going to work with MDD and AUD. I imagine you mentioned that you could combine the program for two indications one molecule but at what point does it make sense to have two separate tracks of clinical trials if there is a point that where it makes sense?
Doug Drysdale: Yes, thanks Andrew for the questions. Yes, I think there is a lot of, there's couple of different areas where it makes sense to combine on the one molecule. The first obviously is in the pre-clinical work way to say one molecule. The second is an early safety and dosing work we'll be looking to find the optimal dose it's likely then that we would separate the MDD and AUD populations, given the different needs they have and maybe in different approaches to psychotherapy. For example in alcohol use, perhaps group therapy would be a benefit and then in terms of the overall exposure renewable safety database are open label exposure studies can contribute to both indications. So we see in synergies across the board and one must be looking to leverage data wherever we can provide indications.
Andrew Partheniou: Okay, thank you for that color and just sticking with CYB003 for a moment what's your - I realize it's early, but what's your expectation for repeat dosing with the data that you have thus far. Is it similar to what we've seen with other players in the industry and other data that we've seen published or do you think that your molecule could be a little different here?
Doug Drysdale: I think it's very hard to tell at this point in time. And when you look at different academic studies with psilocybin, we've seen quite durable effects the recent Phase II study had perhaps most durability then most expected. So, we certainly plan to incorporate multiple dosing into our future clinical programs and the good news is that - if multiple dosing is required to have long durable effect. Then we have a molecule that potentially has half clinic time, so it makes that repeat dosing really a practical reality.
Andrew Partheniou: And on that train of thought, do you have any data or any indications on how to CYB003 is an agonism for the 5-HT2B receptor, and any color on that, given we've seen that receptor potentially having some negative effects on heart valves.
Doug Drysdale: It's good question and I'm going to ask Dr. Palfreyman to talk about maybe the privacy panels that we have done.
Mike Palfreyman: Yes, that's a very good question. When we talk about repeat dosing I wanted to stress that we don't anticipate this to be essentially a daily dosing. This is single doses at suitable intervals between them. And what we do know about the 5-HT2B receptor, and the privacy is that it's only really seen as a problem when you have repeat dosing to stimulate that - a change in the structure of the heart valves. So there is a mechanistic difference and then what we do know is that - this class of compounds, do have some affinity for the receptor. So we are obviously going to, we do include in our preclinical studies in our safety studies looking at those types of risks. What we've seen and what we are very confident about is that the way we've designed our preclinical safety studies corresponds to this concept of repeat dosing, but not repeat every day, but with suitable periods between if you like, individual single dosing. And there - we essentially have I won't say we've eliminated the risk, but the risk is certainly not appeared in the approach we've taken. So if we keep that in mind going forward I think this is a risk factor that we all are very conscious of from historical data with compounds that do affect the 5-HT2B receptor, but we don't believe this with CYB003 and the way would use this compound that that's going to be a deterrent to the types of dosing. I've just described to you
Andrew Partheniou: Thanks for that great color. And maybe just the last one from me if I can fit in here maybe transitioning to CYB004, do you have any color on that, realize that you haven't really talked about it as much as CYB003 thus far, but is there anything that you can share that could point to potentially this drug candidate being more suited to treat anxiety disorders versus what's existing on the market.
Doug Drysdale: Yes, I can say Andrew is that there is some relation between the, work we've been doing on CYB003 and CYB004 in that they are both deuterated tryptamine so some similarities in the work in some consistencies in the results that we've seen. In terms of progress CYB004 is perhaps a quarter or so behind CYB003 we're prioritizing CYB003 but CYB004 is working its way through the preclinical program. So it's good to do these things in a slightly staggered way so you can take learnings from one of the program and apply it to the other. Yes, what I will say about current treatments for anxiety disorders. Is that SSRIs and not particularly well suited for anxiety disorders, they are quite slow to have an effect - six weeks or more in some cases for the patients. I mean it's not just – I think it's a third of patient's respond and maybe 12 weeks for their size in general and for anxiety disorders that's very long, long wait for someone whose life is disrupted by the anxiety. Also some of the side effects that SSRIs analyze like weight gain and sexual dysfunction again, particularly unsuitable for the patients that are suffering from anxiety disorders. So we're hoping with CYB004 given what we know about these tryptamine is an opportunity to have a very rapid onset, and very quick onset of action and those are robust and durable effects, but we'll share more on CYB004 as we work away through our preclinical program.
Andrew Partheniou: Thanks for that color. And I'll get back in the queue.
Doug Drysdale: Thanks Andrew.
Operator: Thank you. Our next question comes from Elemer Piros of ROTH Capital Partners. Elemer, please go ahead. Your line is open.
Elemer Piros: Yes, thank you so much hi Doug. So, just to confirm, CYB004 is an inhaled formulation that you're working on correct?
Doug Drysdale: Well, CYB004 is at deuterated tryptamine that we're working on in the preclinical work of course we're not using an inhaled version of it and in early. In first they really not use a inhaled version of it, but that's our intention, is just to create inhaled version of CYB004, so it becomes similar availability challenges on delivery very rapidly into the blood stream specifier.
Elemer Piros: Okay and I probably didn't hear you correctly or clearly, you were talking about the first responder trial and I think it was mentioned that in the Netherlands is this program with - and with CYB003 or would you please clarify this a little bit?
Doug Drysdale: Yes, the first respond I should say it's not first responders, it's frontline COVID healthcare workers. So those clinicians or those professional have been working, to battle COVID-19 for the last 18 months or so they're facing burnout distress kind of form of PTSD as a result of that. The study is in collaboration with the University of Washington in Seattle and this will be a psilocybin study. That of course as we now know that CYB0003 is a psilocybin analog, we would see the results – it's how to do correlation with the work we do with CYB003.
Elemer Piros: Okay, okay I think it's much clear, thank you. And last question is when you look at the Comp 360 the design and especially the relatively skimpy integration protocol that they had. I think they had two sessions. Do you think you can improve upon that especially since you have or thinking of multiple dosing?
Doug Drysdale: Yes, I will say this is something we feel quite strongly about internally. And as we've looked at other studies academic studies that have either omitted psychotherapy or reduced it significantly. The effects are less impressive and that - the fact that only one prep session was used in the Comp 360 study may have contributed to the sort of lower than expected durability of effect. So our inbox psychotherapy program uses three prep sessions and we think it's important to get patients very well prepared for the treatments. So that the treatment has the most impact.
Elemer Piros: Thank you so much.
Doug Drysdale: Thank you, Elemer.
Operator: Our next question comes from Capital. Seth, please go ahead. Your line is open.
Unidentified Analyst : Thanks and good evening. Doug, congrats on the continued expansion of your footprint in the space, obviously you guys just got DA manufacturing license. I just wanted to get some color on what that opens you up to and if there is other labs that you have that you expect would also need to get better if that's really the one license you need?
Doug Drysdale: Yes, thanks for the questions Seth. So we've been working with as you heard many, many partners across North America and Europe over the last year or more in the conservative activities from synthesis to preclinical work to getting ready for clinical studies. And so, we've been able to tap into this ecosystem of it feels so partners that were necessary, have the right on scheduling, scheduled lines controlled substance licenses. So it hasn't slowed us down at all. But what the benefit of having our own internal Schedule 1 license from a DA means that we can do much at the early discovery work internally and that means a far more rapid turnaround from results to mix deterioration and it also means reduce costs as well as just a more efficient way to do that work at that particular stage. So that's exciting that our internal team term completion head and now I'll have to rely on external partners to do some of that over the year.
Unidentified Analyst : Got it, got it. So that kind of high quality cGMP API you need for the trial will that be kind of acquired at your own facilities or is that more down the line?
Doug Drysdale: So this is small scale and laboratory and it's called manufacturing but it's ready for small scale use. We've already secured supplies cGMP level materials as I mentioned supply chain in U.K. and the U.S. has been established that we'll be able to supply our clinical studies. So that's, we've given ourselves the flexibility to work in multiple jurisdictions, but also on importantly having backup supplies so that we have options going forward the clinical supplies on for commercial supplies.
Unidentified Analyst : Awesome, awesome. Just one last question from me, speaking on the multiple jurisdictions I heard some mention of the potential for a pre-IND discussion, do you plan to have similar discussions with the MHRA, in terms of like an advisory panel. And do you think that there'll be a potential update to the market around your development plans and maybe the trial design and things like that coming into the back of that sort of discussion and early next year?
Doug Drysdale: Yes, it's a good question. So, we expect to reach out for scientific advice from the MHRA, very shortly, actually and hoping we can have discussions with them and with the FDA in the first quarter. I think if there is, if those conversations as per they will, if they inform our decisions around clinical trial design, then we can certainly provide an update to the market on that.
Unidentified Analyst : Perfect. Well, thanks for the color today. Take care.
Doug Drysdale: Thank you very much and thank you to everyone for all the questions. At this point, it's 5:30. And we have to run - to other meetings. So I want to thank you all very much for your time today to please putting the time to listen to the business update and for all the questions. Thank you very much and have a good night.
Operator: Thank you, ladies and gentlemen this concludes today's call. Thank you for joining, you may now disconnect your lines.
