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Cybin Inc.
11/13/2025
Good morning and thank you for joining the Sibon Second Quarter 2026 Financial Results and Corporate Update Call. As a reminder, our press release detailing today's updates is available in the Investors section of our website. On today's call, you will first hear from Eric So, Sibon's Interim Chief Executive Officer and Executive Chair. Following Eric's remarks, Amir Inimdar, CYBIN's Chief Medical Officer, will provide an update on our lead programs CYB003 and CYB004. Finally, Greg Cavers, CYBIN's Chief Financial Officer, will review the financials. Eric will then return with closing comments before we open the lines for Q&A. Before we get started today, I would like to remind everyone that certain statements in this update are forward-looking statements and are perspective in nature. In preparing these forward-looking statements, several assumptions were made by SIBIN, and there are risks that actual results obtained by the company will differ materially from these statements. The company cannot guarantee that any forward-looking statement will materialize, and you are cautioned not to place undue reliance on them. We refer current and potential investors to the forward-looking information sections of the company's management discussion and analysis available at feederplus.ca and on EDCIR at sec.gov. Forward-looking statements represent SIBIN's expectations as of November 13, 2025. Except as required by securities laws, SIBIN does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. I will now turn the call over to Eric for his introductory remarks.
Good morning, and thank you for joining us. This is an important quarter for Siben, one that sets the stage for an active year of milestones. In September, Doug Drysdale stepped down as Chief Executive Officer. On behalf of the Board and the company, I want to thank Doug for his contributions. As co-founder and executive chair, I stepped in as interim CEO to lead the transition while maintaining continuity and momentum. The Board's search for a permanent CEO is underway. Through this transition, our priorities remain the same. patient-focused rigorous science, disciplined execution, and clear communication. We have tightened operational cadence and disclosure discipline, and we'll be adding targeted talent and scientific advisory board expertise to support late-stage execution and launch readiness. Our strategy starts where care happens, in the clinic. What I mean by this is that we are designing therapy days that fit within existing schedules with short, predictable sessions and a staff-light workflow that clinic teams can run without new infrastructure. From there, our focus turns to maintaining wellness. Durability is built into the plan with an efficient retreatment approach that aims to reduce visit burden compared with today's multidisciplinary standards so clinics can scale capacity and patients can plan their lives. Progress with regulators follows the same discipline. We move step-by-step, anchored in data rather than speculation, and we'll communicate milestones as they are achieved. The capital plan matches that pace. Following our recent $175 million financing, we are focusing on advancing our programs towards major data readouts. With that context, let me turn to the quarter and the progress we've made. Before we proceed to the agenda, a brief overview of our pipeline. For those of you who are new to the side and story, we have two lead programs. Side 003, our proprietary deuterated psilocin analog, is in phase three studies for potential adjunctive treatment of major depressive disorder. And side 004, our deuterated dimethyltryptamine, or DMT program, for the potential treatment of generalized anxiety disorder, is in phase two. Clinically, our Phase III SIDE003 program, which has been giving breakthrough therapy designation in major depressive disorder, has continued to progress, including being granted additional clearances to commence EMBRACE, our second Phase III study, and new geographies. In generalized anxiety disorder, the Phase II SIDE004 study completed enrollment and remains on track for our first calendar quarter 2026 top-line readout. Amir will share more details about both programs shortly. At the same time, we advance preparations for scale, including manufacturing and commercial groundwork aligned to a practical clinic workflow. We also strengthen our capital position with the closing of a significant registered direct offering, which provides flexibility to execute through upcoming milestones with clear internal decision gates by program. Across both programs, we are deploying capital with discipline. We are prioritizing global site activation and conduct for embrace and approach, database lock and analysis for side 004, and manufacturing readiness for side 003. With that framework in mind, I'd like to turn the call over to our Chief Medical Officer, Amir Memdar, to review our clinical and regulatory process. He'll begin with SIDE003 and major depressive disorder, focusing on that study status, global footprints, and how the design supports real-world clinic operations and durable outcomes. Dr. Amandar will then review SIDE004 and generalized anxiety disorder, including trial design, operational status following enrollment completion, and the timing and scope of the next data update.
Thank you, Eric. Our Phase III paradigm program is moving forward as planned. Dosing is underway in approach across US sites and participants have rolled over into extent to generate durability data once the double blind period concludes. In parallel, EMBRACE has been cleared to commence in the United States, UK, multiple countries in the European Union and Australia, giving us a truly global footprint. The study targets approximately 330 participants cross about 60 clinical sites and is structured with three arms to evaluate two active doses against placebo in patients with depression whose symptoms remain inadequately controlled on background therapy. The primary endpoint is the change from baseline in Madras total score at six weeks after the first dose. The design is built for clinical reality. TYB003 is intended to run as a predictable staff light session that fits within existing clinic infrastructure. Prior clinical data showed sustained response and remission at 12 months after two 16 milligram doses. And our extension work is aimed at translating that durability into an efficient re-treatment approach that reduces visit burden compared with today's multi-visit standards. On the regulatory front, A posture remains conservative and specific. Near-term touchpoints focus on clean study conduct, global site activation, and data quality reviews as we advance towards pivotal readouts. In anxiety, the work is tracking on schedule. We have completed enrollment in the randomized double-blind phase two study of CYB004 and remain on track for top-line data in the first calendar quarter of 2026. The study evaluates two intramuscular doses given three weeks apart with efficacy assessed at 6 and 12 weeks and optional follow-up out to 12 months. The design permits concomitant antidepressants or anxiolytics and allows comorbid depression, which helps the results reflect real clinical populations. Just as important, Intramuscular administration supports short, predictable sessions that fit a standard clinic day so sites can manage throughput with existing rooms and personnel. The protocol also captures information to guide an efficient retreatment approach if patients need it, aligning durability with practical clinic operations. I will now turn the call back to Eric to discuss the platform and commercial readiness.
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