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spk05: Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to SIBIN's third quarter fiscal year 2022 earnings call. At this time, all participants are in 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 on how to queue your questions. I would also like to remind everyone that this conference call is being recorded today, Thursday, February 10th, 2022, at 8.30 a.m. Eastern Time. I will now turn the call over to Sibon's Vice President of Investor Relations, Leah Gibson. Ms. Gibson, please go ahead.
spk01: Thank you, Bailey. Good morning and welcome to Sibon's third quarter conference call. This is Leah Gibson, Vice President of Investor Relations for Sibon. With me on today's call is Doug Drysdale, Chief Executive Officer of Sibon. And we will also be joined by our COO, Aaron Bartolone, Chief R&D Officer, Mike Palfreman, 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 are perspective in nature. In preparing these forward-looking statements, several assumptions were made by Saibin 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. Saiban refers current and potential investors to the forward-looking information sections of its management's discussion and analysis, available at CEDAR.com and on EDGAR at SEC.gov. Excuse me. Forward-looking statements represent CYBIN's expectations as of February 10, 2022. 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. And with that, I'll turn the call over to Doug.
spk04: Thanks, Leah. Good morning, everyone. Thanks for joining the call today. The third quarter ended December 31st, 2021, was truly active and productive for Saeben, and we're pleased that that momentum has continued into the new year. During the quarter, we achieved several notable accomplishments to help support the evolution of our ecosystem, including the following. Receiving a Schedule 1 manufacturing license from DEA to expand our internal R&D capabilities in Boston, announcing positive data for our tutorated psilocybin analog, CYB3, that demonstrated significant advantages over all psilocybin in preclinical studies, receiving FDA approval for a first-of-its-kind neuroimaging study with psychedelics using kernel flow technology, launching the Embark Psychedelic Facilitator training program and integrating it into a phase two investigator initiated study evaluating psilocybin for clinically depressed healthcare providers and subsequent to the quarter receiving a u.s patent grant for our deuterated dmt molecule cyb4 covering composition of matter we continue to make great progress advancing our psychedelic based compounds into clinical development which we will discuss in detail shortly and we're pleased to announce that we have completed over 140 preclinical studies since the beginning of 2021. The rate at which we're completing these important studies has escalated tremendously, with over 50 of these studies completed in January 2022 alone. This is a true testament to Simon's hard work and commitment to progressing psychedelics into therapeutics as quickly as possible for patients in need. During the past several months, we have built a strong foundation to support this work. We now have excellent partners across North America and Europe to prepare for clinical studies, and we have established strong supply chains to ensure continuity in carrying out our programs on both sides of the Atlantic. In parallel, we have grown our internal team and believe that we have the right people, talented leaders, industry veterans, and accomplished scientists to turn our vision of improving treatments for multiple mental health disorders into a reality. We're also pleased that Cybin is garnering increased interest throughout the investment community. Our stock, the first psychedelic sector, the first stock in the psychedelic sector to trade on the New York Stock Exchange is now covered by nine equity analysts, and we recently were named one of the top five psychedelics companies to watch in 2022. So we're pleased that our strategic approach, including proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches is resonating. The need to address mental health disorders can't be overstated. While the challenge to find better treatments has been with us for decades, the impact of the pandemic has exacerbated the mental health crisis enormously. The impact on individuals, families and society as a whole has never been greater, and the numbers are practically staggering. As we've shared before, the World Health Organization estimates that mental health disorders affect more than 900 million people globally. Depression is widespread, with an estimated 800,000 deaths by suicide worldwide every year. And alcohol-related deaths worldwide account for another 3 million deaths. With this great need comes a large addressable market. As part of Simon's commitment to focus on patient accessibility, we're very proud of our support for Lenox Hill Hospital through a grant awarded last November. Lenox Hill Hospital is the flagship Manhattan hospital of Northwell Health. the largest healthcare system in New York State. This grant is for the first hospital-based psychedelic treatment clinic to serve marginalized and underserved communities. These clinicians will also receive training in EMBARQ, our transdiagnostic psychedelic psychotherapy model, which is one example of our efforts to build a thoughtful ecosystem to support the creation of safe, effective, and accessible psychedelic-based therapeutics for everyone in need. As you've heard us say before, our goal is to harness the potential power and efficacy of psychedelics and develop therapeutic versions of these molecules that potentially offer less variability, fewer side effects, and that can be more scalable and accessible for patients and providers and payers. Much is understood about these molecules as they've been studied in academia for decades at esteemed institutions such as Johns Hopkins, NYU, and Imperial College in London, to name a few. But there is still much work to be done. At Cybin, we're using medicinal chemistry and drug delivery technologies to modify these molecules and leverage the base of data that's already out there to de-risk our development programs and improve the patient experience. In this way, we can capture the potential efficacy demonstrated in these studies, but overcome and improve on some of the specific limitations. We're doing that by currently developing analogs and derivatives of psilocybin, DMT, and other tryptamines and phenethylenes in order to turn these classical psychedelic molecules into approvable prescribable therapeutics. So let me walk you through some of these opportunities, starting with CYB3, our most advanced candidate. CYB3 is a deuterated analog of psilocybin. Deuteration is simply substituting hydrogen atoms on these tryptamine molecules with deuterium, which is heavy hydrogen. Deuteration affects the PK curve, and the breakdown of these molecules in the body. It also helps with interpatient variability by improving metabolic stabilization and brain penetration. So we've been using this process to modify a range of cryptamines, and we've selected a PK profile that we believe will benefit patients and providers and payers. And with our CYB3 program, we're targeting the treatment of major depressive disorder, or MDD, and alcohol use disorder, or AUD. We're currently in the process of wrapping up our preclinical work, which should be completed around the end of this quarter. These studies have revealed that compared to traditional classical psilocybin, CYB3 may result in half the time in the clinic for patients, and perhaps a reduced dose, potentially reducing the side effects and intubation variability. Overall, we believe that we can produce a therapeutic with less variability in plasma levels, faster onset of action, shorter duration in the clinic, and potentially better tolerability. We're planning to submit regulatory applications for our first in-human Phase I-IIa clinical trial in the second quarter of this year. In preparation for those submissions, we have aligned our materials, and contract research organizations and aim to initiate the phase one to a trial in MDD patients around mid-year. I'm pleased to report that we recently had a productive scientific advice meeting with the UK MHRA to gain alignment on next steps for advancing our first in human clinical trial, evaluating CYB3 for the treatment of major depressive disorder. We now believe that we have the necessary clarity and support for our clinical trial design as we get ready to enter clinical development. Let me say a few words about our clinical path to proof of concepts. Our approach to clinical development for CYB3 will be to conduct a randomized, double-blind, placebo-controlled Phase I-IIa trial. Participants will receive two doses And response and remission is assessed at week three after a single dose, and again at week six after a second dose. This phase one 2A trial design allows us to accomplish three very important things. First, to assess the safety and efficacy of CYB3 in patients suffering from MDD. Second, to evaluate a range of doses to identify an efficacious dose. and third, to evaluate the impact of more than one administration on efficacy. Dependent on recruitment and enrollment, we may see some interim PK and safety data from this study toward the end of this year. In summary, based on preclinical data, we believe CYB3 provides therapeutic advantages over all psilocybin, and its lower variability could potentially translate into more predictable dosing and better patient outcomes. It also presents an opportunity to combine MDD and AUD treatments into a single program that is protected by a family of patent filings, resulting in overall cost savings and efficiencies in drug development. We see enormous potential to reduce time and resource burden on patients, providers, and payers by improving scalability and accessibility of treatment.
spk02: Moving on to CYB4.
spk04: CYB4 is our proprietary deuterated version of dimethyltryptamine, more commonly known as DMT, that we are evaluating for the treatment of anxiety disorders. CYB4 has been designed to optimize the PK curve of DMT, changing it from a short, sharp spike to smoothing out that curve, keeping the patient in the therapeutic window for a longer period of time, We aim to effectively treat anxiety disorders with improved control through a reduced dose for better safety, increased duration of effect, and potentially alleviating negative experiences versus classical DMT. And we'll certainly take our learnings from our CYB3 program and apply them here. Now, like CYB3, CYB4 is a 5-HT2A receptor agonist. And like DMT, CYB4 as agonistic actions on a range of 5-HT receptors. Efficacy has been demonstrated in a range of observational and real-world studies in depression, anxiety, and substance use disorders. Our goal is to combine CYB4 with an approved inhalation platform, as DMT is not orally bioavailable, and utilize the lungs as a route of administration for very rapid onset and precise control when dosing. As announced just yesterday, we were granted a U.S. patent covering CYB4 with protection out to 2041. As our first-ever Seidman patent issue, this is both a significant and critical milestone for the company as it provides solid protection to our growing intellectual property portfolio of psychedelic-based compounds and further supports and protects the investments that we're making in our CYB4 program. With strong IP protection in place and a clear path to clinical development, we plan to file a regulatory application for a pilot study in the second quarter of 2022 and initiate the study in quarter three of this year. Turning now to CYB5, a proprietary discovery phase phenethylamine derivative. These are molecules that are like MDMA and mescaline. Based on what we know about our CYB5 assets from early research, there's potential for this molecule at low doses to effectively treat neuroinflammation and at high doses to treat psychiatric conditions. Our CYB5 lead asset is a very potent 5-HT2A agonist with oral bioavailability, great brain penetration, and limited peripheral exposure. And it is psychoactive. We're seeing head twitch responses in animal models and are observing quite a long duration with CYP5. That combination of characteristics means that this could be an infrequently dosed chronic treatment at non-psychedelic doses. We're also seeing evidence of anti-inflammatory properties which could then be deployed potentially in a number of neurology or psychiatry conditions, potentially Alzheimer's or Parkinson's disease. While this is outside Cybin's core interest of psychiatry, it looks to be a very interesting molecule and we believe we could build value in this asset through a strategic partnership. And we're working tirelessly to learn more about CYB5 through continued preclinical research. Outside of our internal programs, we're honored to be a co-sponsor in an investigator-initiated trial that is being conducted at the University of Washington that is evaluating our EMBARQ psychotherapy program with psilocybin for frontline clinicians experiencing COVID-related clinical depression. We've all watched the news reports describing the impact of the pandemic on our frontline workers, doctors, nurses, therapists, and other healthcare workers in hospitals and nursing homes. They're burned out and traumatized by the sheer magnitude and unrelenting surge of critically ill COVID patients. So this study is timely, but also long overdue. The phase two trial will enroll approximately 30 frontline clinicians with clinically significant symptoms of depression and anxiety, which is the primary measure, and existential distress, the secondary measure, following work exposure during the COVID-19 pandemic. The trial will aim to treat symptoms of depression, anxiety, burnout, and post-traumatic stress among frontline professionals. The study received IRB approval in November 2021 and is currently enrolling participants. We see this as an important opportunity to better understand the effectiveness of EMBARQ, our six-domain model of psychedelic-assisted psychotherapy, co-developed by our Chief Clinical Officer, Dr. Alex Belser. EMBARQ was designed as a transdiagnostic psychotherapy model that can be adapted to address a range of clinical indications and populations. And importantly, learnings from this combination phase two trial will inform the use of EMBARQ in our upcoming human studies using CYB3 and CYB4. Another external program that we're very excited about is the company-sponsored feasibility study in collaboration with Kernel, evaluating its Kernel Flow quantitative neuroimaging technology to measure psychedelic effects on cerebral cortex hemodynamics. Kernel Flow uses pulsed light instead of continuous wave light to increase measured brain information. In contrast to FLRI studies that require a patient to lie in a scanner, KernelFlow is easily wearable. The entire system is the size and look of a bicycle helmet. Through the KernelFlow technology, the study is exploring the possibility to measure longitudinal brain activity before, during, and after a psychedelic experience. and collect quantitative data instead of having to rely on subjective patient reporting. The study received IRB approval in January and is projected to kick off soon. This is groundbreaking work that we hope will test the effectiveness of psychedelic treatments and further support our mission to develop psychedelics into therapeutics. So entering 2022, we really are firing on all senators. And while we've accomplished a lot in a relatively short space of time, we still have a great deal of work ahead. And we believe that 2022 will be a truly transformative year for cyber. Turning now briefly to our financials as of December 31st, 2021, our cash and cash equivalents totaled $63.6 million. Our cash-based operating expenses totaled $12 million for the quarter ended December 31st, 2021, of which $2.5 million were one-time non-recurring costs. Non-cash expenses for the quarter totaled $5.2 million for a total net loss of $17.2 million. We will now open the call up for questions from our analysts on the line. Bailey, please go ahead with the instructions. Thank you.
spk05: Thank you. If you would like to ask a question, please press star followed by the number one on your telephone keypad. If you would like to remove your question for any reason, please press star followed by two. Okay, we do have our first question. Our first question comes from Sumanth Kulkarni from Canaccord. Your line is open. Please go ahead.
spk06: Good morning. Thanks for taking my questions. I have a couple. The first is on regulatory interactions and the second is a pipeline one. So you provided some details on your interactions with UK regulators. Could you characterize any interactions you've had with the FDA already, if any? And now that we've had phase 2B data on psilocybin, there are a few other programs out there, including yours, that involve psilocybin analogs and other molecules that DMT and 5-neur DMT are getting riper from an industry pipeline perspective. Do you expect the FDA to issue any formal guidance on the use of psychedelic therapeutics?
spk04: Good morning, Samantha. Good to hear you. Thanks for the question. We had a very positive meeting with the MHRA, positive and productive. I think we got some very valuable responses and feedback to our questions from them. Obviously, we're not going to put words in their mouth, but I will say that we're continuing as planned and they're very encouraged by what we heard. We've had interactions with the FDA, not directly had a meeting yet specifically on CYB3, and we don't anticipate that we will need to do that as we're on track to file an IMD in the second quarter of this year. Regarding your question about guidance, honestly, I'm not sure when we'll see guidance. I'm not sure there's enough evidence or data yet necessarily to support guidance but i wouldn't be surprised if some guidance came in in the future as we get through more of these phase two studies and we learn more about various aspects of of dosing placebo and various other things but uh not hearing anything just just yet you got it and then on the pipeline um cyb3 how do you expect that molecule to interact when used with alcohol and on o4
spk06: Could you give some details on the inhalation dosing? Are there any chances of getting this as a drug device combo patentability from that perspective?
spk04: So maybe I'll take that one first, in that we have three families of patents, one covering our family of tryptamines, protecting the CYB3 and CYB4 programs. The second family of filings is around the phenethylamine programs that we're working on. And the third family is around delivery, including various forms of inflation, et cetera. So we're certainly hoping that as those issue, there'll be opportunities for further protection, further IP protection. Our general thinking at the moment is targeting the formulation of CYB4 into a nebulizer, which would provide either a powder or a liquid, simple nebule that would go into an approved device. So we certainly want to retain that pathway and the benefits that it brings, but without adding unnecessary regulatory hurdles. And then on the alcohol question for CYB3, alcohol use disorder is still of high priority for us. We are prioritizing MDD first. And so that's why you're seeing the MDD study beginning this year, in the middle of the year. And we'll share more on the AED program as we get through that early proof of concept.
spk00: Thank you.
spk05: Thank you for your question. The next question comes from Charles Duncan from Canter Fitzgerald. Charles, please go ahead.
spk07: Yes, good morning. Thanks for taking the question, Doug and team. Congrats on the progress as well as the recent 04 patent. Yeah, had a couple of questions. Number one, with regard to the CYB03 trial in MDD, can you give us a little bit of sense of timing? I know, you know, MDD is a big issue, but when would you be able to, or when do you anticipate being able to provide updates from that trial in terms of how it's going or even the incremental safety updates and early observations? Then I had a follow-up question on that trial.
spk04: Hey Charles, good morning. Thanks for the questions. So yes, we're on track to file our IND for the second quarter and look to kick off the study around mid-year. we're pretty encouraged by what we're seeing in terms of interest in the study. I can tell you that in our investigative-initiated trial with the University of Washington that began enrolling in December, there's already a waiting list of 1,000 patients for that study. So I don't see at this point enrollments and recruitment being a huge hurdle. So that's good news. I think we should be able to get the study moving quite quickly, and we have our CROs ready to go. In terms of data, I expect that by year end, we should have some view of PK and safety. And that's really critical for us. I mean, I think we take a lot of comfort from the Comp360 Phase 2 study that clearly showed efficacy with psilocybin. So given that CYB3 is a psilocybin analog, we're fairly confident in efficacy. Of course, what we're really wanting to show here in this proof of concept is not just efficacy, but that we can improve the PK profile with CYB3, that faster onset, shorter duration, and interpatient variability. So certainly we should get a glimpse into that by the end of this year is our hope.
spk07: Very good. And then with regard to that trial, Doug, I'm wondering if, First of all, you'll follow patients beyond, say, the initial six weeks. You said that you look at responses at three and six weeks, but would you follow out to, say, 12 weeks or longer? And then I guess I'm just wondering if you could maybe speculate on the biological rationale for a shorter duration trip, if you will, or psychedelic experience. resulting in quality experience that can drive efficacy. It seems like shorter duration may be enabling of still a quality experience that could drive efficacy, but I'm just kind of wondering if you have a sense of the biological rationale for that.
spk04: Yeah, thanks for the question. Regarding the study, obviously we have interest in following up And as we share our clinical trial design with FDA and get that confirmed, and I think we'll get into more specifics on the study. I don't want to get into too many details until that's approved. But clearly, we think the durability of effect is very important. And that's why we're going to repeat those studies. When we look at academic studies out of Johns Hopkins and NYU, those studies that are most impressive are used more than one dose. And so we think that's likely necessary. And one of the benefits of CYB3 is that patients will likely spend much less time in the clinic. So adding a second dose into the psychotherapy program and the dosing regimen, if that leads to longer durability, then of course I think that's a great trade-off. And I think durability is where the real paradigm shift is here with these treatments, of course. You know, there are shorter acting molecules, ketamine, DMT, that appear to have benefit. CYB3 is not super short acting. It's still likely to be in that two hour or so time frame. So a decent amount of time in that therapeutic state. And so that combined with the repeat dosing, we hope has some meaningful impacts on durability. Okay.
spk07: Last quick question for you, and appreciate the color on that, is actually hopping over to 04. I'm really intrigued with deuterated DMT for anxiety. And I guess I'm wondering, in terms of being a value creating over the current forms of DMT, I guess I'm wondering, I haven't looked at the patent yet. But what is the key observation that you see in that patent or with your candidate 04 that really is a differentiator?
spk04: So the patent, Charles, covers composition of matter for CYB4 and also actually a number of other deuterated forms of DMT and 5-MeO DMT. So that gives us some future options as well potentially. What you see with classical DMT is a very short duration and quite an aggressive PK spike, really patients going up and down within maybe 10 minutes. And that really takes them up above what we think is a necessary therapeutic window and can create anxiety in patients as they get that rush. And back to your previous question about duration, perhaps that short amount of time is not long enough for patients to be in the therapeutic state. So the benefits of deuterating DMT are that it slows the breakdown of DMT in the body by monoamine oxidase. So we can slow down that curve and get patients into the therapeutic window in a smoother way for a longer period of time that we should be able to titrate with the inhalation platform. So it's really about removing the anxiety, getting patients into the zone, if you like, quickly into the therapeutic state, and then being able to get them out of that state in a manageable period of time that helps with scalability and accessibility.
spk07: Excellent. So kind of the opposite, but the same as CYB003, two different strategies, but similar kind of innovations.
spk04: You're right. And of course, you know, these two molecules, psilocybin and DNT, have slightly different receptor profiles. We know there's a lot of blurring of the edges, if you like, between conditions, comorbidities, between anxiety and PTSD and depression. So we think that offering a range of options for physicians helps them to match the right treatment with the right patient.
spk07: Absolutely. Makes sense. Thanks for taking my questions. Congrats on the progress.
spk04: Thank you, Charles.
spk05: Thank you, Charles. The next question comes from Sefa Manacheri from 8 Capital. Please go ahead. Your line is open.
spk03: Thanks and good morning. Thank you for taking my questions and congrats on the recent milestones. A number of my questions were already answered, but I just want to start with the regulatory discussions and the discussions with regulators that you've been having. I'm happy to hear you guys have gained insights from the MHRA and want to kind of know if you can share your thoughts on placebo as part of your program moving forward. Is that going to be similar to the Compass placebo in terms of the one milligram dose? And can you kind of share and characterize that?
spk04: Yeah, I can. Seth, good morning. Thanks for the question. Our plan is to use a true placebo in this initial study. I'm not entirely convinced that we have evidence that using a one milligram or two milligram of psilocybin has any real benefit over a true placebo. But I do think that this is potentially an open question for regulators as we go forward. I think if the study is well controlled, patients are selected in the right way and screened, and they have good preparation and dosed appropriately, that we should see, as we've seen in the academic studies, some quite meaningful and quite large effect sizes. So not too concerned about the placebo or complicating the issue of placebo at this point, but I do think maybe that's a question for regulators as Miracle would.
spk03: Got it. And I guess, will there be some case masking in place to establish or will there be some sort of other controls put in place in your mind to kind of put in place certain characteristics that equivalent the placebo?
spk04: Yeah, we'll make sure that the trial is fully blinded, of course.
spk03: And in terms of the design for that phase one, two trial, Do you have insight into how you'll be designing the inclusion criteria and if it may have potential to give you a postdoc analysis to look at maybe drinking days and be able to maybe get some pilot data for your AUD program after the MDD cohort or it will then not be powered to that size?
spk04: Yeah, I mean, these are two very different populations, the MBD population and the AUD populations. Broadly speaking, I can tell you that the inclusion criteria will be patients with moderate to severe depression that are not currently controlled or feel like they're not controlled. And we'll also, importantly, be leaving patients on their SSRIs. And we think this is an important point in that when we've seen two or three now small studies that indicate that leaving patients on their SSRIs may be either neutral to slightly positive. But on the downside, when you look at taking patients off their SSRIs and titrating them down, we saw recent evidence that the rebound effects from that titration could last as long as 12 months. So it's not really practical, I think, in a clinical study or in the real world to titrate patients off their SSRIs. So we think it makes much more sense to position CYB3 as an adjunctive therapy. So I think that is an important difference as we look at this study. It's positioned as adjunctive with patients staying on their SSRIs and we're doing repeat dosing.
spk03: Yeah, no, that and the placebo are both key checkmarks in terms of differentiating the study and it's likely for success. Just the last one from me, you characterized some of your discussions with regulators. So have you had a pre-IND meeting with the FDA, or do you plan to, or has that just been more kind of consultant-based discussions?
spk04: Well, we're very lucky to have strong advisors, including Tom Loughran, who was head of FDA psychiatry for 25 years. So we have pretty good insight into that. We have met with Health Canada, and we have met with the MHRA, so we've had some good input from regulators. We've submitted information to the FDA. We're not expecting to have a pre-IND meeting. We're on track to submit our IND in the second quarter.
spk03: Understood. So the IND submission is the next step. There's no pre-IND meeting ahead. Understood. Thanks for answering the questions. Thanks, sir.
spk04: Thank you.
spk05: Thank you. The next question we have comes from Patrick Truccio from HC Wainwright. Patrick, please go ahead.
spk09: Good morning. Thank you for taking my question today. And this is Jason speaking for Patrick. And congrats on the milestones that you guys have for this year. So I just have two quick questions, kind of expand a little bit more on CYB3. And so kind of the first one is that how soon after the completion of phase one could the program transition to the phase 2A study? And what do you anticipate the baseline characteristics of the patients enrolled in the phase 2A portion of the program? And do you have any idea of the powering study, how the powering study could look like in terms of the MADRS scale improvement?
spk04: Yeah, thank you, Jason, for the questions. This is going to be a nested study, so we're not anticipating a true phase one aspect of the study. We're expecting to move right into patients with MDD, so there won't be a delay of moving into MDD patients, which will save us a considerable amount of time and not have to go through that healthy cohort process. That's our anticipation, at least. We'll see what the regulators say, but we're feeling pretty confident about that. As I mentioned, these are expected to be patients with moderate to severe MDD. And I believe that this study is designed for a two-point difference on the matter of scale. But of course, we're clearly expecting more than that based upon evidence that's out there. But as we get through the IMD process and we finalize and agree the protocol with regulators, we'll share the final details with you all.
spk09: All right, so that's a favorite additional color and I just have a follow up question just kind of like discussing a little more about embark on. And so, like what is the status of the phase two co fund investigated initiated trial at the University of Washington and came to mind is kind of like the protocol. On that will be used for the program including like how many sessions of therapy sessions and total and also how long session will be and then kind of just finally. Do you anticipate having learnings from Phase 2 study utilizing Embark that could be applied to the Phase 2 study for CYB3?
spk04: Some great questions. Thank you. Yeah, so the Embark study at the University of Washington is going to be very valuable, we think, in helping us prepare for our MDD study. We trained the investigators and therapists at the end of last year. and learned a lot from that process of putting the training modules together and delivering the training. And, of course, we'll be learning from the logistics of the deployment of Embark through that study. So I think it was a smart thing to do to have kind of a test run for Embark, if you like, with this smaller study before we move into our MDD study. That study at the University of Washington is enrolling. It began enrolling in December 2017. As I mentioned already, I believe there's a thousand or so participants waiting in line for that study. So this has got an awful lot of interest. I think that bodes well for recruitment for our MDD study going forward. The study is a single dose of psilocybin. It's 25 milligrams of psilocybin versus a 2 milligram placebo. So we may get some insight from that, although it's a fairly small study. And yes, we're using the Madras scale to measure changes versus baseline there. The Embark program that we're using that's been adapted for that study is three prep sessions and up to three integration sessions. As I said, this is a kind of test run, a pilot run, so we can learn from Embark deployment. And I definitely see opportunities as we move forward to work to optimize the program as we move closer to commercialization.
spk09: All right, fantastic.
spk04: Thank you so much for the extra call. Thank you.
spk05: Thank you, Patrick. The next question comes from Francois Brisbois from Oppenheimer. Francois, please go ahead.
spk08: Hi, thanks for taking the questions. Just a couple here. So, you know, we'll have more detail on the design of Phase 1 to a as you're ready to share more. But I was just wondering with what's shared so far, so the SSRIs and, you know, you won't have to come off the SSRIs, but in terms of the repeat dose, are all patients receiving two doses or is this, and when are they receiving their doses? Is it, you know, two doses off the shot and then off the bat and then at week six you analyze those or just one dose and then you get three, or is it one dose at week, you know, for the first one, and then come week three, you do another dose, and then you check at week six. So, just anything on the timing of those doses that you've shared, just to be clear, on that side would be helpful.
spk04: Yeah, sure. Good morning, Frank. Thanks for the questions. So, we'll have at least three different dose cohorts with escalating dosage strengths of CYB3, and we'll subjects to patients divided into active and placebo, of course. We will dose at time zero for the first dose, active and placebo, and we'll measure response and remission on the Madras scale at week three. And at that point, everyone will receive another dose. So the active patients will receive a second dose at week three. The placebo patients will receive a first dose at week three. So that means that everyone in the study gets to have a dose, meaning that's good for patient retention. And at week six, we'll then measure response and remission again. So we'll see the difference there between one dose and two doses at week six. And we think that that design gets us into patients very quickly. It'll help us determine an efficacious dose by looking at a range of doses and will help us look at the impact of more than one dose on efficacy. So Quite a simple trial design, but we expect to learn quite a lot from them.
spk08: Okay. Okay. So just to be clear, and this is similar to Charles' question from earlier, but so the patients that will receive two doses, since they get those two doses, one was at time zero and one at week three, you will never have more than a three-week duration of someone on two doses. Is that fair?
spk04: Well, I'll say that I think there'd be some benefit in looking at longer-term follow-up. I just can't share the specifics of that with you at this point in time.
spk08: Okay. All right. Just wanted to be clear on that. That's it for me. Thank you.
spk04: Thank you, Frank.
spk05: Thank you. As a reminder, if you would like to ask a question, please press star followed by one on your telephone keypad. Our next question comes from Andrew Partineau from Stifle. Andrew, please go ahead.
spk10: Good morning. Thanks for taking my questions. Maybe just starting off realizing that you may want to limit what you share, but could you talk a little bit about the UK MHRA meeting? What did you learn from that meeting? Any feedback that you could point to that you perhaps didn't expect or that you believe is a useful guide in the design of the trial?
spk04: Hey, Andrew, good morning. Thanks for your questions. Clearly, we got verbal feedback during the meeting, and as I said before, it was positive and productive. I don't want to share too many specifics because regulators get a little bit A bit uncomfortable with that, but we will receive also. We expect some written feedback in due course. No surprises really from us. We're developing CYB3 as a full NCU, a full preclinical package. So our plan is to go right into patients, as I mentioned in this MDD study. And so no surprises that are changing our direction or changing our plan from the meeting. So I think that speaks a lot to the team and the preparation and the level of briefing materials that were provided to the NHRA. I think the team did a fantastic job of being prepared. And it's, I think, a testament to their efforts that we walked out of that meeting feeling very positive and with no surprises.
spk10: Thank you for that. That's encouraging. On CYB05, you mentioned the potential for partnership. Could you point to perhaps an ideal timing within the clinical process that you could look to establishing that partnership? Who could be an ideal partner? And is this specific to this program or Would you be open to partnering for CYB03 and 04 at all?
spk04: Yeah, so interesting question. So CYB5 we think is very interesting. That phenethylamine program has thrown out 50 or so molecules. And so we've looked at an awful lot of different molecules. This one that we're pursuing now has an awful lot of potential, we think, and is the most promising we've seen so far in terms of oral bioavailability, brain penetration, and these potential impacts on neuroinflammation at low doses. So a really interesting molecule. Clearly, the kind of low-dose chronic approach for inflammation is a little bit outside of psychiatry that we would typically pursue. And we want to stay very very much focused on on those lead programs. So we have already begun conversations with a number of pharmaceutical companies I'll say that I wish in quite a big change from last year where big pharma was I think sitting on the sidelines a little bit and maybe poking around a little bit but I Will say that the interests across a wide range of pharma companies seems to be quite intense now in psychedelics teams fully engaged and involved, asking all the right questions around IP and trial designs and commercialization models. So I certainly expect, probably in the sector, there to be more transactions over the next year. A natural fit for this molecule would be companies with existing CNS franchises, I would expect, given that neuroinflammation could potentially have benefits in Parkinson's or Alzheimer's or maybe even MS.
spk10: Thanks for that detailed question, detailed answer. And just more of a housekeeping question, you provided some good additional guidance on future expenses in the MD&A. Could you discuss the timing and cadence of those expenses And anything that you could point to, you know, that drove the increase that maybe wasn't expected? Are you thinking about accelerating any of your programs or anything that, you know, you might want to identify that's out of the ordinary?
spk04: Yes, so you're right. I think we provide quite a lot of detail in terms of breaking out our spend by program in our MD&A, which was filed today. And also we'll make available on our investor relations website as well. So a lot of detail there and happy to follow up with any specific questions. You know, as I mentioned, I may have mentioned to you before, Andrew, I think our run rate looks like it's going to be around $10 million a quarter. And we've certainly seen a flattening of our SG&A spend and increase in our R&D spend as 2021, calendar 21 progressed. And we'll see that continuing. But that $10 million per quarter may fluctuate up a little bit or down a little bit based upon R&D spend needed in any particular quarter for any program. But that's really the focus. The bulk of the spend in the next 12 months will be around those CYB3 and CYB4 programs.
spk10: Thanks very much for that, and I'll get back in the queue.
spk05: Thanks, Andrew. Thank you. Our last question comes from Michael Oakenwich from Maxim Group. Michael, please go ahead.
spk02: Hey, guys. Thanks for taking the question. I guess for the first one, I'd like to ask regarding the Embark program. Is there an opportunity to continue this development to bring a psilocybin program to approval or potentially have some sort of licensing partnership through Embark? Or is this more so just to demonstrate the actual Embark psychotherapy protocol for use with your next-gen compounds?
spk04: Hey, Michael, and thanks for the question. Yeah, I think I understand what you're asking. Yeah, we're not at this point looking to progress any of the treatment's specifically for that indication of the Investigating Initiated Study, the COVID-related distress. That's a great opportunity, I think, to help out those healthcare providers and learn more about the molecule. The primary focus for us is developing EMBARQ so that it's a valuable tool for future studies. And we think it is. I think it's important to combine psychotherapy with these molecules. We've certainly seen in academic studies that where psychotherapy or psychological support is reduced or skipped, that the results are less impressive. So we do think that some level of support is important. We've started now recruiting facilitators for our studies. We'll be doing more training over the course of the next several months. And our goal and our plan is to embark as a program, open source, for therapists that want to get trained and want to learn more about psychedelic-assisted psychotherapy.
spk02: All right, thank you. And then I guess as a follow-up, just more broadly, Broadly on the overall strategy, could you discuss a bit about the rationale for the shift in focus towards the earlier stage analog programs from your initial thylacide and sublingual program instead of doing both programs in parallel? I mean, given there are obviously advantages to the analog, but that also comes with a trade-off in times of the number of studies you need to run and the time to market. Could you touch on that a little bit?
spk04: Yeah, absolutely. Thank you. Thanks, Michael. Yes, you're right. Earlier, towards the end of last year, we did refine our focus, and we believe that we have a better plan going forward and a better molecule. There are commercial challenges around an eight-hour psilocybin treatment, and we hear that often from our clinical partners, as well as IP challenges. We've seen some of the IP challenges around psilocybin that make that direct route potentially an issue. So as some of those things became clear, along with the preclinical data that we generated for CYB3, it was obvious to us that although it meant maybe some additional time, we believe that that transition gave us a better overall product profile that ultimately is the important thing, better profile for patients and better IP. And we've always said that focusing on scalable therapeutics and improving patient access So, you know, it's great that we were able to move CYB3 forward so quickly with an IMD filing just coming up in this next quarter and moving into human studies mid-year.
spk02: Thank you. I appreciate the caller. And then just one more, as a point of clarification on the 1.2a. I might not have caught this, but I just wanted to make sure. Will the study start in MDD patients, or will you need an additional phase one safety cohort in healthies?
spk04: At this point in time, obviously subject to the regulators, we expect to be able to move straight into patients with MDD. So we'll still be collecting that PK and safety data that will be necessary, but directly from patients rather than healthy volunteers. That's the current expectation, you know, I'm going to give you the caveat subject to the IND approval.
spk02: Yeah, but if that is the case, you could see some preliminary efficacy by year end, correct?
spk04: I think we'll see at least preliminary PK and safety by year end with the efficacy coming shortly after that. All right.
spk02: Thank you very much.
spk04: Thanks, Michael.
spk05: Thank you, Michael. There are currently no questions registered. So I'd like to hand the conference back over to Doug Drysdale for closing remarks. Doug, please go ahead. Thanks, Bailey.
spk04: Thank you, everyone. Thanks for the time today. You know, we talk about our programs, but what we're really focused on here is addressing the mental health crisis. And I think it's paramount as we continue forward. as a global society, try and cope with this widespread and lingering effects of the COVID-19 pandemic. Our work is and always has been carried out with patience, top of mind. We're combining our internal team, our scientific team, with an ecosystem of external partners to move our psychedelic-based compounds through development and the regulatory process as quickly as we can, and ultimately to ensure that the best access that we can deliver for patients that are so desperately in need of more effective treatments. So thank you for joining today and stay safe.
spk05: That concludes the Cybern Incorporation Third Quarter Fiscal Year 2022 Earnings Call. Thank you for your participation. You may now disconnect.
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