Cybin Inc. (CYBN) on Q3 2022 Results - Earnings Call Transcript
Operator: Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to Cybin's Third Quarter Fiscal Year 2022 Earnings Call. . I would also like to remind everyone that this conference call is being recorded today, Thursday, February 10, 2022, at 8:30 a.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, Billy. Good morning, and welcome to Cybin's third 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. In 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 section of its management's discussion and analysis available at sedar.com and on edgar@sec.gov. 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, whether as a result of new information, future events or otherwise. And with that, I'll turn the call over to Doug.
Douglas Drysdale: Thanks, Leah. Good morning, everyone. Thanks for joining the call today. The third quarter ended December 31, 2021, was truly active and productive for Cybin. 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 the DEA to expand our internal R&D capabilities in Boston; announcing positive data for our deuterated psilocybin analog, CYB003, that demonstrated significant advantages overall 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 II investigator-initiated study evaluating psilocybin for clinically depressed health care providers; and subsequent to the quarter, receiving a U.S. patent grant for our deuterated DMT molecule, CYB004, 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 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 Cybin'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 9 equity analysts. And we recently were named 1 of the top 5 psychedelics companies to watch in 2022. So we're pleased with 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 metal health crisis enormously. The impact on individuals, families and society as a whole has never been greater. And the numbers are, frankly, 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 Cybin'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 health care system in New York State. This grant is the first hospital-based psychedelic treatment clinic to serve marginalized and underserved communities. These clinicians will also receive training in EMBARK, our trans-diagnostic psychedelic psychotherapy model, which is one example of our efforts toward 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's 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 derisk 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 phenethylamines in order to turn these classical psychedelic molecules into approvable prescribable therapeutics. So let me walk you through some of these opportunities. Starting with CYB003, our most advanced candidate. CYB003 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 inter-patient variability by improving metabolic stabilization and brain penetration. So we've been using this process to modify a range of tryptamines, and we selected a PK profile that we believe will benefit patients and providers and payers. And with our CYB003 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, CYB003 may result in half the time in the clinic for patients and perhaps a reduced dose, potentially reducing the side effects and inter-patient 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 I/IIa trial in MDD patients around midyear. I'm pleased to report that we recently had a productive Scientific Advice Meeting with the U.K. MHRA to gain alignment on next steps for advancing our first-in-human clinical trial evaluating CYB003 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 CYB003 will be to conduct a randomized, double-blind, placebo-controlled Phase I/IIa trial. Participants will receive 2 doses, and response and remission is assessed at week 3 for a single dose and again at week 6 for a second dose. This Phase I/IIa trial design allows us to accomplish 3 very important things: first, to assess the safety and efficacy of CYB003 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 the study toward the end of this year. In summary, based on preclinical data, we believe CYB003 provides therapeutic advantages over oral 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. Moving on to CYB004. CYB004 is our proprietary deuterated version of dimethyltryptamine, more commonly known as DMT, that we are evaluating for the treatment of anxiety disorders. CYB004 has been designed to optimize the PK curve of DMT, changing it from a short, sharp spike, just 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 CYB003 program and apply them here. Now like CYB003, CYB004 is a 5-HT2A receptor agonist. And like DMT, CYB004 has 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 CYB004 with an approved inhalation platform as DMT is not orally bioavailable, and utilize the lungs as a route of administration for a very rapid onset and precise control when dosing. As announced just yesterday, we were granted a U.S. patent covering CYB004 with protection out to 2041. As our first-ever Cybin 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 CYB004 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 3 of this year. Turning now to CYB005, a proprietary discovery-phase phenethylamine derivative. These are molecules that are like MDMA and mescaline. Based on what we know about our CYB005 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 CYB005 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 CYB005. 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 can build value in this asset through a strategic partnership. And we're working tirelessly to learn more about CYB005 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 EMBARK psychotherapy program with psilocybin for frontline clinicians experiencing COVID-related clinical depression. We've all watched the news reports describing the impacts of the pandemic on our frontline workers, doctors, nurses, therapists and other health care 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 II 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 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 EMBARK, our sixth domain model of psychedelic-assisted psychotherapy co-developed by our Chief Clinical Officer, Dr. Alex Belser. EMBARK was designed as a trans-diagnostic psychotherapy model that can be adapted to address a range of clinical indications and populations. And importantly, learnings from this combination Phase II trial will inform the use of EMBARK in our upcoming human studies using CYB003 and CYB004. 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 fMRI studies that require a patient to lie in a scanner, Kernel Flow is easily wearable. The entire system is the size and look of a bicycle helmet. Through the Kernel Flow 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 ground-breaking work, but 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 cylinders. 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 Cybin. Turning now briefly to our financials. As of December 31, 2021, our cash and cash equivalents totaled $63.6 million. Our cash-based operating expenses totaled $12 million for the quarter ended December 31, 2021, of which $2.5 million were onetime nonrecurring costs. Noncash 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. Billy, please go ahead and -- with the instructions. Thank you.
Operator: . Okay. We do have our first question. Our first question comes from Sumant Kulkarni from Canaccord.
Sumant Kulkarni: I have a couple. The first is on regulatory interactions and the second is the pipeline one. So you provided some details on your interactions with the U.K. regulators. Could you characterize any interactions you've had with the FDA already? And now that we've had Phase IIb data on psilocybin, there are a few other programs out there, including yours, that involve psilocybin analogs and other molecules of DMT and 5-MeO-DMT are getting ripe for -- from an industry pipeline perspective. Do you expect the FDA to issue an informal guidance on the use of psychedelic therapeutics?
Douglas Drysdale: Sumant, it's good to hear you, thanks for the question. We had a very positive meeting with the MHRA, positive and productive. And we've 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 we're very encouraged by what we heard. We've had interactions with the FDA, not directly had a meeting yet specifically on CYB003. And we don't anticipate that we will need to do that as we're on track to file an IND 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 the future as we get through more of these Phase II studies, and we learn more about various aspects of dosing, placebo and various other things, but not hearing anything just yet.
Sumant Kulkarni: Got it. And then on the pipeline, CYB003, how do you expect that molecule to interact when used with alcohol? And on 004, 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?
Douglas Drysdale: So maybe I'll take that one first and that we have three families of patents covering -- one covering our family of tryptamines, protecting the CYB003 and CYB004 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 inhalation, et cetera. So we're certainly hoping that those -- as those issue, there will be opportunities for further protection -- further IP protection. Our general thinking at the moment is targeting the formulation of CYB004 into a nebulizer, which would provide either a powder or a liquid, a simple nebule that'll 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 CYB003, 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 AUD program as we get through that then early proof of concept.
Operator: The next question comes from Charles Duncan from Cantor Fitzgerald.
Charles Duncan: Doug and team, congrats on the progress as well as the recent 004 patent. Yes, I had a couple of questions. Number one, with regard to the CYB003 trial in MDD, can you give us a little bit of sense of timing? I 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 the -- even the incremental safety updates and early observations? Then I had a follow-up question on that trial.
Douglas Drysdale: Charles, thanks for the questions. So yes, so we're on track to file our IND for the second quarter and look to kick off the study around midyear. We're pretty encouraged by what we're seeing in terms of interest in the study. I can tell you that in our investigator-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 II study that clearly showed efficacy with psilocybin. So given that CYB003 is a psilocybin analog, well, we're fairly confident in efficacy. And 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 of -- with CYB003, that faster onset, shorter duration and inter-patient variability. So certainly, we should get a view and a glimpse into that by the end of this year is our hope.
Charles Duncan: Very good. And then with regard to that trial, Doug, wondering if, first of all, you'll follow patients beyond, say, the initial 6 weeks. You said that you'll look at responses at 3 and 6 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.
Douglas Drysdale: Yes. 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're getting them 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 as well, yes, I'm going to repeat those study. When we look at academic studies of Johns Hopkins and NYU, those studies that are most impressive use more than one dose, and so we think that's likely necessary. And one of the benefits of CYB003 is that patients will spend -- likely to spend much less time in the clinic. So adding a second dose into the psychotherapy program and the dosing regimen, if that leads to, along the 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. There are shorter-acting molecules, ketamine, DMT that appear to have benefit. CYB003 is not super short-acting. We're still likely to be in that 2-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.
Charles Duncan: Next quick question for you, and I appreciate the color on that, is actually hopping over to 004. I'm really intrigued with deuterated DMT for anxiety. And I guess, I'm wondering, in terms of being 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 004 that really is a differentiator?
Douglas Drysdale: So the patent, Charles, covers composition of matter for CYB004 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 we're seeing with -- 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 that it slows the breakdown of DMT in the body by monoamine oxidase. And 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 the state in a manageable period of time, that helps with scalability and accessibility.
Charles Duncan: Excellent. So kind of the opposite, but the same as CYB003, 2 different strategies, but similar kind of innovation.
Douglas Drysdale: You're right. And of course, these 2 molecules, psilocybin and DMT 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 they're offering a range of options for physicians. It helps them to match the right treatment with the right patient.
Charles Duncan: Absolutely. Makes sense. Congrats on the progress.
Douglas Drysdale: Thank you, Charles.
Operator: Thank you, Charles. The next question comes from Sepehr Manochehry from Eight Capital.
Sepehr Manochehry: Congrats on the recent milestones. A number of my questions are already answered, but I just want to start with the regulatory discussions with regulators that you've been having. I'm happy to hear you guys have gained insights from the MHRA, and I wanted 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 1 milligram dose? And can you kind of share -- I mean, characterize that?
Douglas Drysdale: Yes, I can, Sep. 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 1 milligram or 2 milligram of psilocybin has any real benefit over a tryp 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. They have good preparation and dosed appropriately that we should see, as we've seen in the academics, so there's some quite meaningful and quite large effect sizes. So I'm 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 we move forward.
Sepehr Manochehry: 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?
Douglas Drysdale: Yes. We'll make sure that the trial is fully blinded, of course.
Sepehr Manochehry: And in terms of the design for that Phase I/II trial, do you have insight into how you'll be designing the inclusion criteria? And if it may have potential to give you a post-hoc analysis to look at maybe drinking days and being able to maybe get some pilot data for your AUD program after the MDD cohort? Or will they not be powered to that size?
Douglas Drysdale: Yes. I mean, these are two very different populations, the MDD population and the AUD populations. Broadly speaking, I can tell you that the inclusion criteria would be patients with moderate to severe depression that are not currently controlled or feel like they're not controlled. And we're also, and importantly, be leaving patients on their SSRIs. And we think this is an important point in that when we've seen 2 or 3 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, I assume we saw a 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 CYB003 as an adjunctive therapy. So I think that is an important difference as we look at the study. It's positioned as adjunctive with patients staying on their SSRIs, and we're doing redosing.
Sepehr Manochehry: Yes. No, that and the placebo are both key checkmarks in terms of differentiating the study, and its likely hold 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?
Douglas Drysdale: Well, we're very lucky to have strong advisers, including Tom Laughren, 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.
Sepehr Manochehry: Understood. So the IND submission is the next step. There's no pre-IND meeting ahead? Understood.
Operator: The next question we have comes from Patrick Trucchio from H.C. Wainright.
Jason Shieh: This is Jason speaking for Patrick. And congrats on the milestones that you guys have for this year. So I just have 2 quick questions, kind of expand a little bit more on CYB003. And so kind of the first one is that, how soon after the completion of Phase I could the program transition to the Phase IIa study? And what do you anticipate the baseline characteristics of the patients enrolled in the Phase IIa portion of the program? And do you have any idea of the PARI study or how the PARI study could look like in terms of the majors -- scale improvement?
Douglas Drysdale: Yes. Thank you, Jason, for the questions. This is going to be a nested study. So we're not anticipating a true Phase 1 aspect of the study. We're looking -- we're expecting to move right into patients with MDD. So there won't be a delay of moving in to MDD patients, which will save us some 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 is designed for a 2-point difference on the matter of scale. But of course, we're clearly expecting more than that based upon evidence that's out there. Look, as we get through the IND process and we finalize and agree the protocol with regulators, we'll share the final details with you all.
Jason Shieh: All right. So thanks, Doug, for the early -- additional color. And I just have a follow-up question, just kind of like discussing a little bit more about EMBARK. And so like what is the status of the Phase II co-funded investigator-initiated trial at the University of Washington? And can you remind us of kind of like the protocol that will be used for the program, including like how many therapy sessions in total? And also how long the session will be? And then kind of just finally, do you anticipate having learnings from Phase II study utilizing EMBARK that could be applied to the Phase IIa study for CYB003?
Douglas Drysdale: Some great questions, thank you. Yes, 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 University of Washington is enrolling. It began enrolling in December. As I mentioned already, I believe, there's 1,000 or so participants waiting in line for that study. So that's 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, there'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 matter of scale to measure changes versus baseline there. The EMBARK program that we're using that's been adapted for that study is 3 prep sessions and up to 3 integration sessions. As I said, this is a kind of test run, the 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.
Operator: Thank you, Patrick. The next question comes from François Brisebois from Oppenheimer.
François Brisebois: Just a couple here. So we'll have more detail on the design of the Phase I/IIa as you're ready to share more, but I was just wondering with what's shared so far. So the SSRIs will not have -- you won't have to come off the SSRIs. But in terms of the repeat dose, are all patients receiving 2 doses? Or is this -- and when are they receiving their doses? Is it 2 doses off the shot and then -- off the bat and then at week 6, you analyze those? Or just 1 dose and then you get 3? Or is it 1 dose at week -- for the first one and then come week 3, you do another dose and then you check at week 6? So just anything on the timing of those doses that you've shared, just to be clear on that side, would be helpful.
Douglas Drysdale: Yes, sure. Frank, thanks for the questions. So we'll have at least 3 different dose cohorts with escalating dosage strengths of CYB003 and subject to the patients, divided into active and placebo, of course. We will dose at time 0 for the first dose, active and placebo, and we'll measure response and remission on the matter of scale at week 3. And at that point, everyone will receive another dose. So the active patients will receive a second dose at week 3. The placebo patients will receive a first dose at week 3. So that means that everyone in the study gets to have a dose, meaning that's good with patient -- for patient retention. And at week 6. we'll then measure response and remission again. So we'll see the difference there between 1 dose and 2 doses at week 6. And we think that, that design gets us into patients very quickly. It will 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 that.
François Brisebois: Okay. Okay. So just to be clear, and this is similar to Charles' question from earlier, but -- so the patients that will receive 2 doses, since they get those 2 doses, 1 was at time 0 and 1 at week 3, you will never have more than a 3-week duration of someone on 2 doses. Is that fair?
Douglas Drysdale: Well, yes, I'll say that I think there'll 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.
François Brisebois: Perfect. All right. Just wanted to be clear on that. That's it for me.
Douglas Drysdale: Thank you, Frank.
Operator: . Our next question comes from Andrew Partheniou from Stifel.
Andrew Partheniou: Maybe just starting off, realizing that you may want to limit what you share, but could you talk a little bit about the U.K. 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?
Douglas Drysdale: Andrew, thanks for your questions. Look, clearly, we got verbal feedback during the meeting. And as I said before, it was positive and productive. Yes, and I don't want to share too many specifics because regulators get a little 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 CYB003 as a full -- or a full pre-clinical 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 that's -- I think that speaks a lot to the team and the preparation and the level of briefing materials that we provide -- provided to the MHRA. I think the team did a fantastic job of being prepared. And kind of -- I think it's a testament to their efforts that we walked out of that meeting feeling very positive and with no surprises.
Andrew Partheniou: All right. That's encouraging. On CYB005, 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 CYB003 and 004 at all?
Douglas Drysdale: Yes. So interesting question. So CYB005, 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 is 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 is a little bit outside of -- for information, is a little bit outside psychiatry that we would typically pursue, and we want to stay very much focused on those lead programs. So we have already begun conversations with a number of pharmaceutical companies. I'll say that we're seeing 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 interest across a wide range of pharma companies seems to be quite intense now in psychedelics. The team's 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. And 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.
Andrew Partheniou: 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 that drove the increase that maybe wasn't expected? Are you thinking about accelerating any of your programs or anything that you might want to identify that's out of the ordinary?
Douglas Drysdale: Yes. So you're right, I think we provided quite a lot of detail in terms of breaking out our spend by program in our MD&A, which is filed today, and is 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. As I mentioned -- I may have mentioned before, Andrew, I think that run rate looks like it's going to be around $10 million a quarter. And we've definitely seen a flattening of SG&A spend, an increase in our R&D spend as 2021 -- calendar '21 progressed, and we'll see that continuing. 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 as we -- the bulk of the spend in the next 12 months will be around those CYB003 and CYB004 programs.
Operator: Our last question comes from Michael Okunewitch from Maxim Group.
Michael Okunewitch: So 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?
Douglas Drysdale: Michael, thanks for the question. Yes, I think I understand what you're asking. We're not at this point looking to progress any of the treatments specifically for that indication for the -- of the initiated -- investigator-initiated study, that COVID-related distress. That's a great opportunity, I think, to help out those health care providers and learn more about the molecule. But the primary focus for us is developing EMBARK so that it's a valuable to for future studies, and we think it is. I think it's important to combine the psychotherapy with these molecules. We're certainly seeing 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 make EMBARK as a program, open source for therapists that want to get trained and want to learn more about psychedelic-assisted psychotherapy.
Michael Okunewitch: All right. And then, I guess, as a follow-up, just more 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 psilocybin 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?
Douglas Drysdale: Yes, absolutely, thank you. Thanks, Michael. Yes, so 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 8-hour psilocybin treatment, and we hear that often from 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 CYB003, 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 is important. So it's great that we are able to move CYB003 forward so quickly, with an IND filing just coming up in this next quarter and moving into human studies midyear.
Michael Okunewitch: I appreciate the color. And then just one more, as a point of clarification on the I/IIa, I might not have called this, but I just wanted to make sure, will the study start in MDD patients? Or will you need an additional Phase I safety cohort in healthies?
Douglas Drysdale: 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 would be necessary, but directly from patients rather than healthy volunteers. That's the current expectation. I'm going to give you the caveat, subject to the IND approval.
Michael Okunewitch: Yes. But if that is the case, you could see some preliminary efficacy by year-end, correct?
Douglas Drysdale: I think we'll see at least preliminary PK and safety by year-end, with the efficacy coming shortly after that.
Operator: 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.
Douglas Drysdale: Thanks, Billy. Thank you, everyone. Thanks for the time today. We talked 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 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 patients, 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 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.
Operator: That concludes the Cybin Inc. Third Quarter Fiscal Year 2022 Earnings Call. Thank you for your participation. You may now disconnect.
