Cybin Inc.

Good afternoon ladies and gentlemen and thank you for standing by welcome to SIBIN's second quarter fiscal year 2022 earnings call at this time all participants are in a listen-only mode following the prepared remarks we will conduct a question and answer session open to financial analysts instructions will be provided at that time for you to queue up for your questions i would also like to remind everyone that this conference call is being recorded today Monday, November 15, 2021, at 4.30 p.m. Eastern Time. I will now turn the call over to CYBIN's Vice President of Investor Relations, Leah Gibson. Ms. Gibson, please go ahead.

Thank you, Nadia, and welcome to CYBIN's second quarter conference call. This is Leah Gibson, Vice President of Investor Relations for CYBIN. With me on today's call is Doug Drysdale, Chief Executive Officer of CYBIN. And we will also be joined by our COO, Aaron Bartolone, Chief R&D Officer, Mike Palferman, 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 Siben, 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. Siben refers current and potential investors to the forward-looking information sections of its Management, Discussion, and Analysis available at CEDAR.com and on EDGAR at SEC.gov. Forward-looking statements represent SIBAN's expectations as of November 15, 2021. Except for that which is required by securities laws, SIBAN does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. With that, I'll turn the call over to Doug.

Thanks, Leah. Good afternoon, everyone. And thank you for joining our business update call today. The past 12 months has been a period of rapid scientific exploration and progress for us. And we're thrilled to share our accomplishments with you today. At Cybin, we're on a mission to transform psychedelics into therapeutics. The need for safe and effective mental health treatments has never been greater. The pandemic has exacerbated the mental health crisis around the world, and we are dedicated to researching and developing transformative psychedelic therapeutics to improve treatments for all those who suffer. To achieve this, we have assembled a team comprised of world-class scientists, industry leaders, and external partners so that together we can push the boundaries. We are taking what we already know about classical psychedelics and engineering them with a goal of creating safe, effective, and commercially viable therapeutics for all those in need. We have evolved since our founding into a leading company in the psychedelic industry because we have and continue to evolve our entire ecosystem. By this, I mean we are focused on engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches, and treatment regimens for mental health disorders. I'll describe these in more detail in a few moments. Over the past 12 months, we have intentionally built out an ecosystem to optimize psilocybin therapy, always with patients in mind. We are working hard to create an infrastructure to support the scientific exploration and push the boundaries. Let me touch on some of our recent achievements. To date, we have developed a portfolio of over 50 novel compounds and have expanded our intellectual property to 15 patent filings across three patent families. This is a major differentiator for the company, and we anticipate that we will continue to add to our patent portfolio in 2022. Additionally, we have completed 74 preclinical studies, supporting the advancement of CYB3 and CYB4 toward clinical development, showing key dosing and bioavailability advantages over classical psychedelic molecules, with significant progress made in drug preparation with our partners. First in human studies are expected to begin in early 2022, subject to receipt of all necessary approvals. As a company, we have grown from five employees to 55 and now have a presence in Canada, the US, UK, and Ireland. And we are extremely proud of the fact that we are the first and only company in this sector to be listed on a New York Stock Exchange. Partnerships are also critical to accomplishing our goals. And in the past year, we have established 50 such partnerships with world-class scientists, and advisors, and clinical research organizations. Just recently, the U.S. Drug Enforcement Agency granted us a Schedule I manufacturing license for our Boston area research lab, allowing us to expand our internal research and development capability. And more recently, we received FDA authorization for our sponsored first-of-its-kind feasibility study using Kernel's quantitative neuroimaging technology, Kernel Flow, to evaluate ketamine's effect on brain hemodynamics using a wearable headgear device. We hope that this may allow for quantification of brain activity during a psychedelic experience. We also launched the Embark Psychedelic Facilitator Training Program in collaboration with the University of Washington. in preparation for the first clinical trial of psilocybin-assisted psychotherapy. We are co-sponsoring the study, which addresses COVID-19-related distress in frontline healthcare professionals. We're awaiting final approval in order to begin to initiate this study imminently. We're passionate about helping these healthcare workers, many of whom have suffered tremendously in caring for those gravely ill with COVID-19. and we created our EMBARQ psychotherapy program to support both therapists and patients. And lastly, we recently welcomed Dr. Amir Enamdar as Chief Medical Officer, Dr. Jeff Barton as Head of Research and Development, and Leah Gibson as Vice President of Investor Relations. The SIBIN team has done an extraordinary job advancing our promising approaches to developing safe and effective therapeutics for patients with mental health disorders. Today, I'd also like to share the meaningful advances we are making in our preclinical programs, notably CYB3. Our comparative preclinical data shows multiple potential advantages over classical psychedelic molecules, which we believe may have wide-reaching implications for the treatment of mental health. This work is especially urgent today, as nearly 700 million people globally are affected by some form of depression, addiction, or eating disorder, according to the World Health Organization. Some estimates indicate that anxiety disorders affect up to 12% of the US population. And that's why we're so committed to what we do. Turning now to our drug development program. We have made important scientific progress thus far and continue to add to that progress every day. In order to improve on existing therapeutics, we had to identify the challenges of the molecule itself so that we could address them. There is no doubt that academic studies and a recent phase two study have shown efficacy with psilocybin. Yet our goal is to transform these molecules into potentially useful and practical therapeutics that may ultimately receive regulatory approval, and with the aim of improving the safety profile and treatment protocols to benefit providers, payers, and most importantly, patients. We have had three parallel programs working on psilocybin for the past 12 months, two programs CYB1 and CYB2, looked at formulation approaches. And the third is built around our proprietary psilocybin analog, CYB3. The goal, of course, is to identify the best candidate at the lowest cost to take forward into clinical studies. All of this work is centered around addressing the known challenges of all psilocybin as a therapeutic. And these limitations include three issues. One, high variability in plasma levels, which means the potential for unpredictable patient outcomes, adverse events, and side effects. Two, slow time to onset, meaning patients often have to wait up to an hour and a half to achieve peak effects. And three, long duration of treatment, with some patients experiencing eight-hour clinic days resulting in limited scalability due to the increased time and resource burdens on payers, patients, and providers. We at Cybin believe that we can do better, and we're aiming to do so. We've learned a great deal through our extensive work on CYB1 and CYB2. In the case of CYB1, we selected a lead formulation prototype and made study supplies but the psilocybin release from the sublingual film was still greater than 10 minutes, resolving in the potential for more of an oral release profile than a sublingual release profile. CYB2, on the other hand, is a fast-dissolving oral formulation designed to improve the rate of psilocybin release. And while the dispersion occurred in just seconds, so a vast improvement, the oral nature of the formulation would still resolve in a long duration of action. As you can see, we've taken different approaches to try to overcome some of the challenges of psilocybin and to optimize where we make our development investment. Which brings us to CYB3, a proprietary deuterated psilocybin analog with improved properties. And in our view, cybin is the strongest candidate with which to move forward. We believe that we have a positive obligation from the patient perspective and in terms of delivering value to shareholders to advance only the most promising programs with the most efficient use of capital. CYB3 has been designed with the goal of achieving better patient outcomes, including less variability in plasma levels, faster onset of action, shorter duration of effect, and better brain penetration. We conducted many studies in multiple species with models of psychedelic action, studying pharmacokinetic profiling and following FDA safety requirements for the eventual advancement towards clinical use. All of this was done in order to predict a safe and efficacious human dose. What we found was that CYB3 has the potential to offer three main benefits. One, patient clinic days that are cut in half as a result of 50% reduction in both time to onset and total duration of treatment with CYB3 compared to oral psilocybin, providing for potentially greater access and scalability for providers and payers and patients. Two, approximately half the dose of oral psilocybin to achieve psychedelic effects due to almost two times brain penetration. This could result in less drug in the peripheral circulation and the potential for reduced side effects, such as nausea and headaches, which are commonly seen with psilocybin. And three, more predictable patient responses due to a 50% reduction in variability compared to all psilocybin, resulting in a safer therapeutic profile and the potential for reduced serious adverse events. All in all, CYB3 has been designed with the aim to retain all of the therapeutic potential of oral psilocybin while cutting the duration and the potential for negative effects in half. Importantly, and for the reasons I shared a few minutes ago, we also see this as an opportunity to combine MDD and AUD that is major depressive disorder and alcohol use disorder, into a single program with patent protection from a family of nine file patents. That lends itself to cost savings and efficiencies, and we believe has the greatest potential to deliver positive outcomes for patients. As for next steps with the program, we believe we have built a highly capable internal scientific team and have procured the external partnerships necessary to rapidly advance CYB3 through development. Our plan is to complete the full array of 32 preclinical studies by Q1 2022. Also in Q1 2022, we anticipate completing chemistry, manufacturing and controls, or CMC development, including the production of clinical materials. IMD, or investigational new drug, and CTA, or clinical trial application filings, are expected to be made with the U.S. FDA and the U.K. MHRA, respectively, in quarter two of 2022. Then, early phase clinical trials leveraging our innovative Embark psychotherapy program are expected to subsequently commence in the U.S. and the U.K. following regulatory approvals that quarter. We are very excited by these findings and are well prepared to advance the CYB3 program through these development phases, subject to receiving all necessary approval. And we look forward to keeping you apprised on our progress. The psychedelics industry is rightfully garnering a lot of attention for the groundbreaking work that is underway. The success of last week's Wonderland Conference in Miami is indicative of the promise and the passion in our industry and i believe we all came out of that conference even more confident that as an industry we can research potentially safe effective and accessible psychedelic treatments to patients we believe this is strongly supported by our expectations for cyb3 as well as a look into the first clinical data that has been reported on oral psilocybin from one of our peers we welcome and are excited for about the advancements being made in our industry. Yet we are all too aware of the improvements that still need to be achieved to evolve psychedelics into therapeutics. And that's why we are so excited about the potential for CYB3. Turning now to our financials. As of September 30th, 2021, our cash and cash equivalents totaled $75.2 million. Our net loss was $17.6 million for the quarter ended September 30th, 2021, of which non-cash expenses totaled $6 million and cash-based operating expenses totaled $11.6 million. Thank you for your time and attention today. As we continue to experience the lingering effects of the COVID-19 pandemic, it's absolutely urgent that we work to address the devastating impact of mental health disorders in an ethical and safe way. I'm proud of all that Cybin has accomplished towards its end, and I'm optimistic about our ability to move the needle and work towards researching and developing safer, more effective treatments to all who can benefit. We'll now open up the call for questions from our analysts on the line. Thank you. Operator?