Cybin Inc.

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.

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.

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.