Cybin Inc. — Call Transcript 2025

Good morning, and thank you for joining the Cybin Second Quarter 2026 Financial Results and Corporate Update call. As a reminder, our press release detailing today's updates is available in the investor section of our website. On today's call, you will first hear from Eric So, Cybin's Interim Chief Executive Officer and Executive Chair. Following Eric's remarks, Amir Inamdar, 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 prospective 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 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 CedarPlus.ca and on Edgar at sec.gov. Forward-looking statements represent Cybin's expectations as of November 13th, 2025. Except as 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. 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 Cybin, 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 education, execution, and clear communication. We have tightened operational cadence and disclosure discipline and will 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 Cybin story, we have two lead programs. CYB003, our proprietary deuterated psilocin analog, is in phase III studies for potential adjunctive treatment of major depressive disorder. CYB004, our deuterated dimethyltryptamine, or DMT, program for the potential treatment of generalized anxiety disorder, is in phase II. Clinically, our phase III CYB003 program, which has been given a breakthrough therapy designation in major depressive disorder, has continued to progress, including being granted additional clearances to commence Embrace, our second phase III study, in new geographies. In generalized anxiety disorder, the phase II CYB004 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 CYB004, and manufacturing readiness for CYB003. With that framework in mind, I'd like to turn the call over to our Chief Medical Officer, Amir Inamdar, to review our clinical and regulatory process. He'll begin with CYB003 and major depressive disorder, focusing on that study status, global footprints, and how the design supports real-world clinic operations and durable outcomes. Dr. Inamdar will then review CYB004 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 U.S. sites, and participants have rolled over into Extend to generate durability data once the double-blind period concludes. In parallel, Embrace has been cleared to commence in the United States, U.K., multiple countries in the European Union, and Australia, giving us a truly global footprint. The study targets approximately 330 participants across 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 MADRS total score at six weeks after the first dose. The design is built for clinical reality. CYB003 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 retreatment approach that reduces visit burden compared with today's multi-visit standards. On the regulatory front, our 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 II 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. Thank you, Amir. Our focus is to make these therapies workable in the real world, not just on paper. Achieving that goal begins with dependable supply. With Thermo Fisher in place for both drug substance and capsule drug product in the United States, we have a manufacturing footprint sized for phase III and commercialization, which gives sites the predictability to plan therapy days within their existing four walls. From there, we extend into the clinic. Through our partnership with Osmind, we have access to a broad network of psychiatric practices, point-of-care software, and real-world data, so clinics can map out our protocols onto the schedules they already run. Staggered starts, defined observation windows, and clear rule definitions are intended to support predictable session scheduling within existing rooms and teams without requiring new infrastructure. Throughput only matters if the session itself is practical. CYB003 is designed to live inside a standard interventional psychiatry day, offering predictable timing for patients and staff. CYB004, delivered intramuscularly, targets a brief in-clinic experience that simplifies room turnover and staffing compared with all-day alternatives. The combination is intentional: one program suited to establish clinic rhythms, another built for speed and simplicity, both aiming to raise capacity without raising complexity. Durability is the other half of practicality. Phase II CYB003 data showed sustained response and remission at 12 months after just two doses. Our extension work is there to translate that durability into an efficient retreatment approach. The goal is fewer visits and more efficient planning for clinics and payers alike, with clear criteria for when patients should return, how long a session should take, and how that fits across a full clinic day. We're advancing this platform with a conservative regulatory posture and a disciplined capital plan. Underpinning it all is steady leadership. We manage the CEO transition in an orderly way. The permanent CEO search is active, and our governance, cadence, and disclosure discipline keep the organization aligned as we execute towards the next two major data events. Before I turn the call over to Greg Cavers, our CFO, let me touch on our capital structure. Last month, we closed a registered direct offering with participation from prominent institutional healthcare investors. The structure paired common shares with pre-funded warrants with a partial warrant, aligning capital to near-term objectives and giving us the flexibility to execute. As noted earlier, this was an important step for Cybin. The financing provides the resource to advance our ongoing phase II and phase III trials towards key data readouts. We have used a portion of the net proceeds from the financing to repay the outstanding convertible debentures to High Trail. For the avoidance of any doubt, this debt has been fully retired in full. We believe that participation from such high-quality institutions in the financing reflects confidence in our science, our programs, and our ability to deliver. I'd like to take this opportunity to thank our new investors, as well as existing shareholders and investors, for their continued support of our mission. We could not be happier with the partners that came into this financing and all prior financings that drive our programs forward. Capital deployment is paced to measurable milestones. For CYB003, funds support global phase III execution and manufacturing readiness, so sites have reliable supply and predictable therapy days. For CYB004, resources moved to database lock, protocol-specified analyses, and operational lift to top line. Corporate use remains limited and targeted. The plan bridges us to the next two major data events while preserving flexib ility. As data and regulatory interactions inform the path, we will adjust with discipline and continue to communicate clearly about our progress and next steps. I will now hand it off to Greg Cavers, our CFO, to walk through our second quarter financial results. Thank you, Eric. During the quarter, cash-based operating expenses consisting of research, general, and administrative costs totaled $28.5 million for the quarter ended September 30th, 2025, compared to $18.2 million in the same period last year. Net loss was $33.7 million for the quarter ended September 30th, 2025, compared to a net loss of $41.9 million in the same period last year. Cash flows used in operating activities were $34.5 million for the quarter ended September 30th, 2025, again compared to $19.1 million in the same period last year. Operating loss was $28.9 million, and net loss for the quarter was $33.7 million, or $1.39 per basic and diluted share, based on a weighted average share count of 24.2 million shares. We ended the quarter with cash, cash equivalents, and investments of $83.8 million. Subsequent to quarter end, we closed the financing of $175 million, which together with our quarter-end balance provides flexibility to execute our plan. We continue to allocate capital to measurable milestones, and corporate uses remain limited and targeted. Based on our current operating plan, we expect our cash resources to fund key data readouts in 2026 and fund operations into 2027. I will now hand it back over to Eric for closing remarks. Thank you, Greg. In the quarters ahead, our focus is execution against measurable milestones across the business. For CYB003, we will continue dosing in Approach and expand Embrace site activation across cleared geographies, keeping study conduct and data quality at the center of the plan as we progress towards a phase III top line in Q4 of 2026. For CYB004, the path runs through database lock, protocol-specified analyses, and preparation of a clear top-line package in the first quarter of 2026. In parallel, we will advance commercial and manufacturing readiness so sites have reliable supply and a practical clinic day model as data matures, and we will continue to pace investment to milestones. This forward plan also includes leadership. The CEO search is active and progressing and we will provide an update when there is news. Day-to-day execution remains stable under the current structure with operating cadence and disclosure discipline intact. Taken together, clinical progress, measured capital deployment, commercial preparation, and leadership continuity position the company to navigate the next two data events and the steps that follow. To summarize, we have executed through a leadership transition, advanced our late-stage programs, strengthened the balance sheet, and prepared for scale with a model built for clinical reality. The work ahead is clear. Deliver clean data on time, maintain a conservative and specific regulatory posture, and keep capital focused on milestones that move the programs forward. I want to thank all of our employees, investigators, investors, partners, and most importantly, the patients and families who make this progress possible. We look forward to updating you as we meet our milestones. Operator, please open the phone line for questions. Yes, sir. At this time, if you would like to ask a question, please press the star and one keys on your telephone keypad. You may remove yourself from the queue at any time by pressing star two. Once again, that is star one to ask a question. We will take our first question from Pete Stavropoulos with Cantor Fitzgerald. Please go ahead. Hi, this is Sarah on for Pete. Thanks for taking our questions. Two questions from us, one on the CYB004 and the other one on the 003 program. First off, around 004 and GAD, you completed enrollment in early September. Congratulations on that. You have a readout in 1Q26 where you enrolled a total of 36 patients. What would you like to see from this study that would give you confidence to move forward intoP-III? Is it statistical significance on the primary endpoint? Is it directional data suggesting improvement sufficient? What can we expect to see in 1Q? Are you going to provide the six-week data for the primary endpoint, HAM-A, or will you provide efficacy data through 12 weeks? I can take that one. Thank you, Sarah, for the question. Yes, we've completed enrollment in that study. As you probably know, it's a study with two arms, one low-dose arm, which potentially is subpsychedelic, and a full threshold dose. We look at that as a sort of dose-response type of study. We would love to see some separation between the two. As you stated there, directional data is what we are looking for, a trend in change or trend in separation between the two, and also within subject differences in change from baseline, at least with the threshold dose. This is a proof-of-concept study, not necessarily designed as a fully powered study. If we see a statistically significant difference, we'll be thrilled. As you say, directional data, trend in improvement, and a dose-response between the two arms is what we are looking for. We will share this in first quarter. We will aim to share HAM-A data out through 12. Awesome. Thanks. And then one more question from me. The P-II CYB003 data suggests that two doses may keep patients in remission for up to a year commercially. And then taking into account the psychedelic experience associated with psilocin, what do you see as the minimum durability threshold needed to compete with Spravato? And how are you thinking about the trade-off between durability versus time spent in clinics from both a payer perspective reimbursement? Thanks. Okay. One moment, please, while we reconnect Dr. Amir. Can you hear me now? Sorry, I'm back. Yes, sir. Now loud and clear. Apologies for that. Can you repeat the question? The P-II CYB003 data suggests that two doses may keep patients in remission for up to a year commercially and taking into account the psychedelic experience associated with psilocin. What do you see as the minimum durability threshold needed to compete with Spravato? Yeah. I mean, when you look at the guidance that the agency provides for evaluation of these therapies, they want data up to 12 weeks, which is three months. We would be thrilled to see effects that are maintained out to three months. We are hoping for better. As you know, with our phase II data, we showed durability out to a year. Based on what is the expectation of the agency, 12 weeks at a minimum would be great. All right. Thank you so much. Thank you. Our next question will come from Patrick Trujillo with HC Wainwright. Please go ahead. Thanks. Good morning and congrats on all the progress. I just wanted to get a clarification on the CYB004 program, just in terms of what we should expect as far as statistical powering and the definition of clinically meaningful HAM-A improvement. And then separately, I'm just wondering for CYB003, what operational milestones remain to complete enrollment and Approach and are site activations tracking the plan? Patrick, the question on CYB004. As I stated earlier, it's not a formally powered study. We would, however, be looking at an improvement from baseline within subject within the arms. A clinically meaningful effect would be somewhere around four to five points on the HAM-A. A trend to difference between the two arms would be important as well because we want to look at some dose response between the two arms. Study in the sense that it's not a pivotal study, though statistical significance would be amazing. You had a question on CYB003 as well. CYB003 is tracking as to plan. We remain on target to complete enrollment by mid of next year and deliver top-line data by the end of next year. Great. If I could, just a separate question on, as these programs are advancing into later stage and are in late-stage development, I'm just wondering what has been your engagement with payers at this stage and health economic modeling for both CYB003 and CYB004, and as well with the product profile that's emerging for both of these compounds, how you would expect positioning of them in the market relative to what's already available in TRD with Spravato, given that this is with CYB003, we're looking at MDD, CYB004, GAD. I'm just wondering how you're thinking about this early payer engagement and as well the product profile positioning against both compounds available, but also those that are in development. Hi, thanks for that, Patrick. I'll take this one. I mean, as you might imagine at this stage, it's a little bit early, but payer engagement, of course, has begun. Commenting further, I guess, on how that develops and how ultimately with Spravato, you could compare to the commercial market. All right. One moment. It looks like he has disconnected. If anybody else wants to take this question, while we reconnect him. While George is dialing back in, we have been doing some preliminary market research, but as George reiterated, it is a bit early, at least for CYB004. Both the programs, we see them fitting into what is emerging now as an interventional psychiatry paradigm, which really has been spearheaded with Spravato, creating the infrastructure out there. We see these as intermittent treatments that will fit right into that model where patients come in for treatment on an intermittent basis, have the treatment in the clinic, and then return for their additional dosing as and when necessary. The infrastructure is there. We believe with the GAD for CYB004 and with adjunctive inadequate responders for CYB003, those kind of address the spectrum of the most burdensome or most resource-intensive patients that you typically see in a psychiatry practice. George has reconnected. All right. Thank you. Thank you. We'll go to the next question from Jim Malloy with Alliance Global Partners. Please go ahead. Hello. This is Laura Suriel on for Jim Malloy. Thank you for taking our questions. For the ongoing Approach trial, you mentioned how you're planning to have a total of 45 clinical trial sites within the U.S. Could you provide a bit more detail on the criteria behind choosing these sites and the activation process involved, as well as when you might think you have all 45 of these sites fully activated and on board for the study. Yeah. I can take that. We are using a mixture of sites that are experienced in clinical trials and a smaller proportion of sites that are less experienced in psychiatry trials. We also have a mixture of sites that are experienced in conducting trials with psychedelics. There are other sites that we have included that are experienced in CNS trials in general, but not necessarily psychedelics. As you can imagine, with the number of clinical trials ongoing right now in psychedelics, there is, of course, competition for resources at sites. We have been very careful in selecting sites that, one, either have a proven track record of delivering high-quality data or, if they are not experienced in psychedelics, they have the necessary experience and expertise in the psychiatry space in general in other trials. We are confident that they will deliver good quality data. You referred to the number of sites. Yes, we've got 45 sites selected for this study. Virtually all of them are onboarded by now. What's important is with the number of sites that we have activated, we still remain on track to deliver or complete enrollment by mid of next year with top-line data by the end of the year. Great. Thank you. I know the current focus right now is on the CYB003 and the 004 programs. Can you just provide a bit more color on the preclinical 005 program, maybe just on the status of the preclinical studies and any potential partnership opportunities that you may be in discussions with? Yeah. For CYB005, we are doing a number of preclinical profiling studies to characterize the receptor profile, the brain penetration, as well as the primary and secondary pharmacodynamics with a range of compounds in that class, which we believe would be well suited to actually treat some of the neuropsychiatric conditions where there is significant unmet need. That work is ongoing. When there is information to share with the market, we will do so. Understood. Thank you for taking the question. Thank you. Our next question will come from Eddie Hickman with Guggenheim. Please go ahead. Good morning. Thank you for taking my question. Congrats on all the progress. Just two from me. How much visibility do you have into the blinded baseline patient characteristic data from the Approach study? Can you talk at all about how this patient population will differ from a TRD population as it relates to baseline? Secondly, what agreement do you have with the FDA related to the safety database for 003 and what you'll need to provide in regulatory filing? Is there a minimum number of retreatments per year needed in Extend? Thank you. Can you repeat the second question? Dr. Amir, you're cutting in and out. All right. Please stand by while we reconnect Dr. Amir. Can you hear me now? Yes, sir. Now we can. Yes, I can hear you. Sorry. Do you mind, Eddie, repeating that question? Yeah. I was asking the first question is how much visibility do you have into the blinded baseline patient characteristic data from the Approach study and how this population may differ from a TRD population? On the safety database, what you'll need in a regulatory filing? Is there a minimum number of retreatments per year needed in the Extend trial? Thanks. Yes. Thank you. The safety, as the trial is ongoing, the data is blinded. We are performing checks as necessary or as possible with blinded data, which essentially are quality checks in a blinded manner. Since this is a pivotal trial, we are, of course, being very careful with the data. There are other checks built into the database, which ensures that if there are any flags with respect to data quality, they are raised to us immediately if there is a reason for concern. So far, we have not had anything flagged in the database. We are confident that the data quality is being maintained. In terms of how this is different from the TRD population, this group of patients is earlier in the treatment cycle. These are patients who are inadequately responding, and they may have failed one treatment, or they may have failed one and been on their second treatment, but not adequately responding, but not fully failed. They are not that one-third of the patient population that remains after multiple treatment trials. It is about two-thirds of, if you think of the depression population as a whole, this is the first 2/3 of those patients in the treatment cycle, whereas TRD would be the last 2/3 left after multiple treatment cycles. In terms of AIMS or safety database, the safety database really is a function of the frequency of administration. Given that this is an intermittent treatment, what we have discussed with the agency as part of our BTD discussions is that the data that we will provide to them, the numbers that we will provide to them across the three studies would be sufficient to support an NDA. Of course, again, it depends on what we find out in the long-term extension study with respect to treatment frequency. Great. Thank you so much. Sure. Thank you. Our next question will come from Elemor Piros with Lucid Capital Partners. Please go ahead. Yes. Thank you. I just wanted to get maybe just one tiny detail on the loan repayment. If you could clarify how much was repaid and what was the prepayment penalty or the early repayment fees. Thank you. Yes. We repaid High Trail $20 million, and the repayment fee ended up being 10%. 10%. It wasn't a $50 million loan? Just. Yes. The loan was structured as a convertible debt, and they had converted the other $30 million, approximately. They converted the other. Okay. Okay. That's all. Thank you so much. You're very welcome. Thank you. Our next question will come from Samant Kulkarni with Canaccord Genuity. Please go ahead. Good morning. Nice to see the progress, and thanks for taking our questions. I have three. On CYB003, during your pivotal trial program, how important is it that patients remain compliant with their background antidepressant use? All right. One moment, please. Sorry. I was speaking on mute, Samant, taking that question. For our patients in the Approach study and Embrace, because this is adjunctive, the instructions to the patients and requirements in the protocol is that they remain on their background antidepressant medication. We do not expect them or advise them to come off their antidepressant medication during the treatment period. Got it. On 004, do you see an eventual pivotal program involving an intramuscular route of delivery? What are some of the key challenges with developing an oral formulation? My last question is, what are some of the specific qualities that you believe are must-haves for an incoming CEO? I can take the first two. Eric can take the last one. Right now, yes, intramuscular is the route of administration that we plan to progress in phase III. It's a very convenient form of administration, which also gives us what we need in terms of the plasma exposures and the acute experience, which cannot be achieved with something like oral. With oral, the elimination is pretty rapid. DMT or CYB004 does not reach the plasma PK levels, the threshold that is necessary for a breakthrough experience, which, as we know, is necessary for therapeutic efficacy. That we are achieving with intramuscular, it's well tolerated. That is what we are going to take into phase III. Maybe I can also add in here that the intramuscular route is one that, as we are aware from our market research with the interventional psychiatry clinics, is one that is also being used currently by interventional psychiatrists administering ketamine. That gives us some confidence that it is a route that will reach adoption in the market. With regard to your question regarding CEO qualities, I mean, obviously, we've been at it for only about eight weeks right now. The board is spearheading that process. At the moment, we're looking for the qualities that this company and its shareholders deserve: a successful steward of capital that investors can feel confident in, someone that has executed in the past, bringing a novel drug to market, ideally through commercialization, an individual that has transacted and dealt with big pharma in the past as well. These are all table stakes for us and the next individual that will be sitting in the chair. Got it. Thank you. Thank you. At this time, there are no further questions in the queue. I would like to turn the call back over to Eric for any additional or closing remarks. No further remarks. I just want to thank everybody for attending the call today. It's been a very exciting time for Cybin, and we look forward to delivering some fantastic updates for everybody in the future. Thank you all for your support. Thank you, ladies and gentlemen. This does conclude today's program, and we appreciate your participation. You may disconnect at any time.

Speaker 7: Good morning, and thank you for joining the Cybin Second Quarter 2026 Financial Results and Corporate Update call. As a reminder, our press release detailing today's updates is available in the investor section of our website. On today's call, you will first hear from Eric So, Cybin's Interim Chief Executive Officer and Executive Chair. Following Eric's remarks, Amir Inamdar, 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 prospective in nature. Good morning, and thank you for joining the Cybin Second Quarter 2026 Financial Results and Corporate Update call. good morning and thank you for joining the cybin second quarter 2026 financial results and corporate update call As a reminder, our press release detailing today's updates is available in the investor section of our website. as a reminder our press release detailing today's updates is available in the investor section of our website On today's call, you will first hear from Eric So, Cybin's Interim Chief Executive Officer and Executive Chair. on today's call you will first hear from eric so cybin's interim chief executive officer and executive chair Following Eric's remarks, Amir Inamdar, Cybin's Chief Medical Officer, will provide an update on our lead programs, CYB003 and CYB004. following eric's remarks amir inamdar 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. 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. 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 prospective in nature. before we get started today i would like to remind everyone that certain statements in this update are forward-looking statements and are prospective 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 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 CedarPlus.ca and on Edgar at sec.gov. Forward-looking statements represent Cybin's expectations as of November 13th, 2025. Except as 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. I will now turn the call over to Eric for his introductory remarks. 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 these statements. 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 these statements The company cannot guarantee that any forward-looking statement will materialize, and you are cautioned not to place undue reliance on them. 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 CedarPlus.ca and on Edgar at sec.gov. we refer current and potential investors to the forward-looking information sections of the company's management discussion and analysis available at cedarplus.ca and on edgar at sec.gov Forward-looking statements represent Cybin's expectations as of November 13th, 2025. forward-looking statements represent cybin's expectations as of november 13th 2025 Except as 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. except as 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 I will now turn the call over to Eric for his introductory remarks. i will now turn the call over to eric for his introductory remarks

Speaker 2: Good morning, and thank you for joining us. This is an important quarter for Cybin, 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 education, execution, and clear communication. We have tightened operational cadence and disclosure discipline and will 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. Good morning, and thank you for joining us. good morning and thank you for joining us This is an important quarter for Cybin, one that sets the stage for an active year of milestones. this is an important quarter for cybin one that sets the stage for an active year of milestones In September, Doug Drysdale stepped down as Chief Executive Officer. 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. 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. 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. the board's search for a permanent ceo is underway Through this transition, our priorities remain the same: patient-focused, rigorous science, disciplined education, execution, and clear communication. through this transition our priorities remain the same patient-focused rigorous science disciplined education execution and clear communication We have tightened operational cadence and disclosure discipline and will be adding targeted talent and scientific advisory board expertise to support late-stage execution and launch readiness. we have tightened operational cadence and disclosure discipline and will 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. 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. 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. 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. 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. 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. 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. 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. the capital plan matches that pace Following our recent $175 million financing, we are focusing on advancing our programs towards major data readouts. 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. 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. before we proceed to the agenda a brief overview of our pipeline For those of you who are new to the Cybin story, we have two lead programs. CYB003, our proprietary deuterated psilocin analog, is in phase III studies for potential adjunctive treatment of major depressive disorder. CYB004, our deuterated dimethyltryptamine, or DMT, program for the potential treatment of generalized anxiety disorder, is in phase II. Clinically, our phase III CYB003 program, which has been given a breakthrough therapy designation in major depressive disorder, has continued to progress, including being granted additional clearances to commence Embrace, our second phase III study, in new geographies. In generalized anxiety disorder, the phase II CYB004 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. For those of you who are new to the Cybin story, we have two lead programs. for those of you who are new to the cybin story we have two lead programs CYB003, our proprietary deuterated psilocin analog, is in phase III studies for potential adjunctive treatment of major depressive disorder. cyb003 our proprietary deuterated psilocin analog is in phase iii studies for potential adjunctive treatment of major depressive disorder CYB004, our deuterated dimethyltryptamine, or DMT, program for the potential treatment of generalized anxiety disorder, is in phase II. cyb004 our deuterated dimethyltryptamine or dmt program for the potential treatment of generalized anxiety disorder is in phase ii Clinically, our phase III CYB003 program, which has been given a breakthrough therapy designation in major depressive disorder, has continued to progress, including being granted additional clearances to commence Embrace, our second phase III study, in new geographies. clinically our phase iii cyb003 program which has been given a breakthrough therapy designation in major depressive disorder has continued to progress including being granted additional clearances to commence embrace our second phase iii study in new geographies In generalized anxiety disorder, the phase II CYB004 study completed enrollment and remains on track for our first calendar quarter 2026 top-line readout. in generalized anxiety disorder the phase ii cyb004 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. 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. 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 CYB004, and manufacturing readiness for CYB003. With that framework in mind, I'd like to turn the call over to our Chief Medical Officer, Amir Inamdar, to review our clinical and regulatory process. He'll begin with CYB003 and major depressive disorder, focusing on that study status, global footprints, and how the design supports real-world clinic operations and durable outcomes. Dr. Inamdar will then review CYB004 and generalized anxiety disorder, including trial design, operational status following enrollment completion, and the timing and scope of the next data update. 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. 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. 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 CYB004, and manufacturing readiness for CYB003. we are prioritizing global site activation and conduct for embrace and approach database lock and analysis for cyb004 and manufacturing readiness for cyb003 With that framework in mind, I'd like to turn the call over to our Chief Medical Officer, Amir Inamdar, to review our clinical and regulatory process. with that framework in mind i'd like to turn the call over to our chief medical officer amir inamdar to review our clinical and regulatory process He'll begin with CYB003 and major depressive disorder, focusing on that study status, global footprints, and how the design supports real-world clinic operations and durable outcomes. he'll begin with cyb003 and major depressive disorder focusing on that study status global footprints and how the design supports real-world clinic operations and durable outcomes Dr. Inamdar will then review CYB004 and generalized anxiety disorder, including trial design, operational status following enrollment completion, and the timing and scope of the next data update. dr inamdar will then review cyb004 and generalized anxiety disorder including trial design operational status following enrollment completion and the timing and scope of the next data update

Speaker 9: Thank you, Eric. Our phase III paradigm program is moving forward as planned. Dosing is underway in Approach across U.S. sites, and participants have rolled over into Extend to generate durability data once the double-blind period concludes. In parallel, Embrace has been cleared to commence in the United States, U.K., multiple countries in the European Union, and Australia, giving us a truly global footprint. The study targets approximately 330 participants across 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 MADRS total score at six weeks after the first dose. The design is built for clinical reality. CYB003 is intended to run as a predictable, staff-light session that fits within existing clinic infrastructure. Thank you, Eric. thank you eric Our phase III paradigm program is moving forward as planned. our phase iii paradigm program is moving forward as planned Dosing is underway in Approach across U.S. sites, and participants have rolled over into Extend to generate durability data once the double-blind period concludes. dosing is underway in approach across u.s sites and participants have rolled over into extend to generate durability data once the double-blind period concludes In parallel, Embrace has been cleared to commence in the United States, U.K., multiple countries in the European Union, and Australia, giving us a truly global footprint. in parallel embrace has been cleared to commence in the united states u.k multiple countries in the european union and australia giving us a truly global footprint The study targets approximately 330 participants across 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 study targets approximately 330 participants across 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 MADRS total score at six weeks after the first dose. the primary endpoint is the change from baseline in madrs total score at six weeks after the first dose The design is built for clinical reality. the design is built for clinical reality CYB003 is intended to run as a predictable, staff-light session that fits within existing clinic infrastructure. cyb003 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 retreatment approach that reduces visit burden compared with today's multi-visit standards. On the regulatory front, our 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 II 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. 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 retreatment approach that reduces visit burden compared with today's multi-visit standards. 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 retreatment approach that reduces visit burden compared with today's multi-visit standards On the regulatory front, our posture remains conservative and specific. on the regulatory front our 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. 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. in anxiety the work is tracking on schedule We have completed enrollment in the randomized double-blind phase II study of CYB004 and remain on track for top-line data in the first calendar quarter of 2026. we have completed enrollment in the randomized double-blind phase ii 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 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. 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. 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. 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. 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. i will now turn the call back to eric to discuss the platform and commercial readiness

Speaker 2: Thank you, Amir. Our focus is to make these therapies workable in the real world, not just on paper. Achieving that goal begins with dependable supply. With Thermo Fisher in place for both drug substance and capsule drug product in the United States, we have a manufacturing footprint sized for phase III and commercialization, which gives sites the predictability to plan therapy days within their existing four walls. From there, we extend into the clinic. Through our partnership with Osmind, we have access to a broad network of psychiatric practices, point-of-care software, and real-world data, so clinics can map out our protocols onto the schedules they already run. Staggered starts, defined observation windows, and clear rule definitions are intended to support predictable session scheduling within existing rooms and teams without requiring new infrastructure. Throughput only matters if the session itself is practical. Thank you, Amir. thank you amir Our focus is to make these therapies workable in the real world, not just on paper. our focus is to make these therapies workable in the real world not just on paper Achieving that goal begins with dependable supply. achieving that goal begins with dependable supply With Thermo Fisher in place for both drug substance and capsule drug product in the United States, we have a manufacturing footprint sized for phase III and commercialization, which gives sites the predictability to plan therapy days within their existing four walls. with thermo fisher in place for both drug substance and capsule drug product in the united states we have a manufacturing footprint sized for phase iii and commercialization which gives sites the predictability to plan therapy days within their existing four walls From there, we extend into the clinic. from there we extend into the clinic Through our partnership with Osmind, we have access to a broad network of psychiatric practices, point-of-care software, and real-world data, so clinics can map out our protocols onto the schedules they already run. through our partnership with osmind we have access to a broad network of psychiatric practices point-of-care software and real-world data so clinics can map out our protocols onto the schedules they already run Staggered starts, defined observation windows, and clear rule definitions are intended to support predictable session scheduling within existing rooms and teams without requiring new infrastructure. staggered starts defined observation windows and clear rule definitions are intended to support predictable session scheduling within existing rooms and teams without requiring new infrastructure Throughput only matters if the session itself is practical. throughput only matters if the session itself is practical CYB003 is designed to live inside a standard interventional psychiatry day, offering predictable timing for patients and staff. CYB004, delivered intramuscularly, targets a brief in-clinic experience that simplifies room turnover and staffing compared with all-day alternatives. The combination is intentional: one program suited to establish clinic rhythms, another built for speed and simplicity, both aiming to raise capacity without raising complexity. Durability is the other half of practicality. Phase II CYB003 data showed sustained response and remission at 12 months after just two doses. Our extension work is there to translate that durability into an efficient retreatment approach. The goal is fewer visits and more efficient planning for clinics and payers alike, with clear criteria for when patients should return, how long a session should take, and how that fits across a full clinic day. We're advancing this platform with a conservative regulatory posture and a disciplined capital plan. CYB003 is designed to live inside a standard interventional psychiatry day, offering predictable timing for patients and staff. cyb003 is designed to live inside a standard interventional psychiatry day offering predictable timing for patients and staff CYB004, delivered intramuscularly, targets a brief in-clinic experience that simplifies room turnover and staffing compared with all-day alternatives. cyb004 delivered intramuscularly targets a brief in-clinic experience that simplifies room turnover and staffing compared with all-day alternatives The combination is intentional: one program suited to establish clinic rhythms, another built for speed and simplicity, both aiming to raise capacity without raising complexity. the combination is intentional one program suited to establish clinic rhythms another built for speed and simplicity both aiming to raise capacity without raising complexity Durability is the other half of practicality. durability is the other half of practicality Phase II CYB003 data showed sustained response and remission at 12 months after just two doses. phase ii cyb003 data showed sustained response and remission at 12 months after just two doses Our extension work is there to translate that durability into an efficient retreatment approach. our extension work is there to translate that durability into an efficient retreatment approach The goal is fewer visits and more efficient planning for clinics and payers alike, with clear criteria for when patients should return, how long a session should take, and how that fits across a full clinic day. the goal is fewer visits and more efficient planning for clinics and payers alike with clear criteria for when patients should return how long a session should take and how that fits across a full clinic day We're advancing this platform with a conservative regulatory posture and a disciplined capital plan. we're advancing this platform with a conservative regulatory posture and a disciplined capital plan Underpinning it all is steady leadership. We manage the CEO transition in an orderly way. The permanent CEO search is active, and our governance, cadence, and disclosure discipline keep the organization aligned as we execute towards the next two major data events. Before I turn the call over to Greg Cavers, our CFO, let me touch on our capital structure. Last month, we closed a registered direct offering with participation from prominent institutional healthcare investors. The structure paired common shares with pre-funded warrants with a partial warrant, aligning capital to near-term objectives and giving us the flexibility to execute. As noted earlier, this was an important step for Cybin. The financing provides the resource to advance our ongoing phase II and phase III trials towards key data readouts. We have used a portion of the net proceeds from the financing to repay the outstanding convertible debentures to High Trail. Underpinning it all is steady leadership. underpinning it all is steady leadership We manage the CEO transition in an orderly way. we manage the ceo transition in an orderly way The permanent CEO search is active, and our governance, cadence, and disclosure discipline keep the organization aligned as we execute towards the next two major data events. the permanent ceo search is active and our governance cadence and disclosure discipline keep the organization aligned as we execute towards the next two major data events Before I turn the call over to Greg Cavers, our CFO, let me touch on our capital structure. before i turn the call over to greg cavers our cfo let me touch on our capital structure Last month, we closed a registered direct offering with participation from prominent institutional healthcare investors. last month we closed a registered direct offering with participation from prominent institutional healthcare investors The structure paired common shares with pre-funded warrants with a partial warrant, aligning capital to near-term objectives and giving us the flexibility to execute. the structure paired common shares with pre-funded warrants with a partial warrant aligning capital to near-term objectives and giving us the flexibility to execute As noted earlier, this was an important step for Cybin. as noted earlier this was an important step for cybin The financing provides the resource to advance our ongoing phase II and phase III trials towards key data readouts. the financing provides the resource to advance our ongoing phase ii and phase iii trials towards key data readouts We have used a portion of the net proceeds from the financing to repay the outstanding convertible debentures to High Trail. we have used a portion of the net proceeds from the financing to repay the outstanding convertible debentures to high trail For the avoidance of any doubt, this debt has been fully retired in full. We believe that participation from such high-quality institutions in the financing reflects confidence in our science, our programs, and our ability to deliver. I'd like to take this opportunity to thank our new investors, as well as existing shareholders and investors, for their continued support of our mission. We could not be happier with the partners that came into this financing and all prior financings that drive our programs forward. Capital deployment is paced to measurable milestones. For CYB003, funds support global phase III execution and manufacturing readiness, so sites have reliable supply and predictable therapy days. For CYB004, resources moved to database lock, protocol-specified analyses, and operational lift to top line. Corporate use remains limited and targeted. The plan bridges us to the next two major data events while preserving flexib ility. For the avoidance of any doubt, this debt has been fully retired in full. for the avoidance of any doubt this debt has been fully retired in full We believe that participation from such high-quality institutions in the financing reflects confidence in our science, our programs, and our ability to deliver. we believe that participation from such high-quality institutions in the financing reflects confidence in our science our programs and our ability to deliver I'd like to take this opportunity to thank our new investors, as well as existing shareholders and investors, for their continued support of our mission. i'd like to take this opportunity to thank our new investors as well as existing shareholders and investors for their continued support of our mission We could not be happier with the partners that came into this financing and all prior financings that drive our programs forward. we could not be happier with the partners that came into this financing and all prior financings that drive our programs forward Capital deployment is paced to measurable milestones. capital deployment is paced to measurable milestones For CYB003, funds support global phase III execution and manufacturing readiness, so sites have reliable supply and predictable therapy days. for cyb003 funds support global phase iii execution and manufacturing readiness so sites have reliable supply and predictable therapy days For CYB004, resources moved to database lock, protocol-specified analyses, and operational lift to top line. for cyb004 resources moved to database lock protocol-specified analyses and operational lift to top line Corporate use remains limited and targeted. corporate use remains limited and targeted The plan bridges us to the next two major data events while preserving flexib ility. the plan bridges us to the next two major data events while preserving flexib ility As data and regulatory interactions inform the path, we will adjust with discipline and continue to communicate clearly about our progress and next steps. I will now hand it off to Greg Cavers, our CFO, to walk through our second quarter financial results. As data and regulatory interactions inform the path, we will adjust with discipline and continue to communicate clearly about our progress and next steps. as data and regulatory interactions inform the path we will adjust with discipline and continue to communicate clearly about our progress and next steps I will now hand it off to Greg Cavers, our CFO, to walk through our second quarter financial results. i will now hand it off to greg cavers our cfo to walk through our second quarter financial results

Speaker 10: Thank you, Eric. During the quarter, cash-based operating expenses consisting of research, general, and administrative costs totaled $28.5 million for the quarter ended September 30th, 2025, compared to $18.2 million in the same period last year. Net loss was $33.7 million for the quarter ended September 30th, 2025, compared to a net loss of $41.9 million in the same period last year. Cash flows used in operating activities were $34.5 million for the quarter ended September 30th, 2025, again compared to $19.1 million in the same period last year. Operating loss was $28.9 million, and net loss for the quarter was $33.7 million, or $1.39 per basic and diluted share, based on a weighted average share count of 24.2 million shares. We ended the quarter with cash, cash equivalents, and investments of $83.8 million. Thank you, Eric. thank you eric During the quarter, cash-based operating expenses consisting of research, general, and administrative costs totaled $28.5 million for the quarter ended September 30th, 2025, compared to $18.2 million in the same period last year. during the quarter cash-based operating expenses consisting of research general and administrative costs totaled $28.5 million for the quarter ended september 30th 2025 compared to $18.2 million in the same period last year Net loss was $33.7 million for the quarter ended September 30th, 2025, compared to a net loss of $41.9 million in the same period last year. net loss was $33.7 million for the quarter ended september 30th 2025 compared to a net loss of $41.9 million in the same period last year Cash flows used in operating activities were $34.5 million for the quarter ended September 30th, 2025, again compared to $19.1 million in the same period last year. cash flows used in operating activities were $34.5 million for the quarter ended september 30th 2025 again compared to $19.1 million in the same period last year Operating loss was $28.9 million, and net loss for the quarter was $33.7 million, or $1.39 per basic and diluted share, based on a weighted average share count of 24.2 million shares. operating loss was $28.9 million and net loss for the quarter was $33.7 million or $1.39 per basic and diluted share based on a weighted average share count of 24.2 million shares We ended the quarter with cash, cash equivalents, and investments of $83.8 million. we ended the quarter with cash cash equivalents and investments of $83.8 million Subsequent to quarter end, we closed the financing of $175 million, which together with our quarter-end balance provides flexibility to execute our plan. We continue to allocate capital to measurable milestones, and corporate uses remain limited and targeted. Based on our current operating plan, we expect our cash resources to fund key data readouts in 2026 and fund operations into 2027. I will now hand it back over to Eric for closing remarks. Subsequent to quarter end, we closed the financing of $175 million, which together with our quarter-end balance provides flexibility to execute our plan. subsequent to quarter end we closed the financing of $175 million which together with our quarter-end balance provides flexibility to execute our plan We continue to allocate capital to measurable milestones, and corporate uses remain limited and targeted. we continue to allocate capital to measurable milestones and corporate uses remain limited and targeted Based on our current operating plan, we expect our cash resources to fund key data readouts in 2026 and fund operations into 2027. based on our current operating plan we expect our cash resources to fund key data readouts in 2026 and fund operations into 2027 I will now hand it back over to Eric for closing remarks. i will now hand it back over to eric for closing remarks

Speaker 2: Thank you, Greg. In the quarters ahead, our focus is execution against measurable milestones across the business. For CYB003, we will continue dosing in Approach and expand Embrace site activation across cleared geographies, keeping study conduct and data quality at the center of the plan as we progress towards a phase III top line in Q4 of 2026. For CYB004, the path runs through database lock, protocol-specified analyses, and preparation of a clear top-line package in the first quarter of 2026. In parallel, we will advance commercial and manufacturing readiness so sites have reliable supply and a practical clinic day model as data matures, and we will continue to pace investment to milestones. This forward plan also includes leadership. The CEO search is active and progressing and we will provide an update when there is news. Day-to-day execution remains stable under the current structure with operating cadence and disclosure discipline intact. Thank you, Greg. thank you greg In the quarters ahead, our focus is execution against measurable milestones across the business. in the quarters ahead our focus is execution against measurable milestones across the business For CYB003, we will continue dosing in Approach and expand Embrace site activation across cleared geographies, keeping study conduct and data quality at the center of the plan as we progress towards a phase III top line in Q4 of 2026. for cyb003 we will continue dosing in approach and expand embrace site activation across cleared geographies keeping study conduct and data quality at the center of the plan as we progress towards a phase iii top line in q4 of 2026 For CYB004, the path runs through database lock, protocol-specified analyses, and preparation of a clear top-line package in the first quarter of 2026. for cyb004 the path runs through database lock protocol-specified analyses and preparation of a clear top-line package in the first quarter of 2026 In parallel, we will advance commercial and manufacturing readiness so sites have reliable supply and a practical clinic day model as data matures, and we will continue to pace investment to milestones. in parallel we will advance commercial and manufacturing readiness so sites have reliable supply and a practical clinic day model as data matures and we will continue to pace investment to milestones This forward plan also includes leadership. this forward plan also includes leadership The CEO search is active and progressing and we will provide an update when there is news. the ceo search is active and progressing and we will provide an update when there is news Day-to-day execution remains stable under the current structure with operating cadence and disclosure discipline intact. day-to-day execution remains stable under the current structure with operating cadence and disclosure discipline intact Taken together, clinical progress, measured capital deployment, commercial preparation, and leadership continuity position the company to navigate the next two data events and the steps that follow. To summarize, we have executed through a leadership transition, advanced our late-stage programs, strengthened the balance sheet, and prepared for scale with a model built for clinical reality. The work ahead is clear. Deliver clean data on time, maintain a conservative and specific regulatory posture, and keep capital focused on milestones that move the programs forward. I want to thank all of our employees, investigators, investors, partners, and most importantly, the patients and families who make this progress possible. We look forward to updating you as we meet our milestones. Operator, please open the phone line for questions. Taken together, clinical progress, measured capital deployment, commercial preparation, and leadership continuity position the company to navigate the next two data events and the steps that follow. taken together clinical progress measured capital deployment commercial preparation and leadership continuity position the company to navigate the next two data events and the steps that follow To summarize, we have executed through a leadership transition, advanced our late-stage programs, strengthened the balance sheet, and prepared for scale with a model built for clinical reality. to summarize we have executed through a leadership transition advanced our late-stage programs strengthened the balance sheet and prepared for scale with a model built for clinical reality The work ahead is clear. the work ahead is clear Deliver clean data on time, maintain a conservative and specific regulatory posture, and keep capital focused on milestones that move the programs forward. deliver clean data on time maintain a conservative and specific regulatory posture and keep capital focused on milestones that move the programs forward I want to thank all of our employees, investigators, investors, partners, and most importantly, the patients and families who make this progress possible. i want to thank all of our employees investigators investors partners and most importantly the patients and families who make this progress possible We look forward to updating you as we meet our milestones. we look forward to updating you as we meet our milestones Operator, please open the phone line for questions. operator please open the phone line for questions

Speaker 7: Yes, sir. At this time, if you would like to ask a question, please press the star and one keys on your telephone keypad. You may remove yourself from the queue at any time by pressing star two. Once again, that is star one to ask a question. We will take our first question from Pete Stavropoulos with Cantor Fitzgerald. Please go ahead. Yes, sir. yes sir At this time, if you would like to ask a question, please press the star and one keys on your telephone keypad. at this time if you would like to ask a question please press the star and one keys on your telephone keypad You may remove yourself from the queue at any time by pressing star two. you may remove yourself from the queue at any time by pressing star two Once again, that is star one to ask a question. once again that is star one to ask a question We will take our first question from Pete Stavropoulos with Cantor Fitzgerald. we will take our first question from pete stavropoulos with cantor fitzgerald Please go ahead. please go ahead

Speaker 1: Hi, this is Sarah on for Pete. Thanks for taking our questions. Two questions from us, one on the CYB004 and the other one on the 003 program. First off, around 004 and GAD, you completed enrollment in early September. Congratulations on that. You have a readout in 1Q26 where you enrolled a total of 36 patients. What would you like to see from this study that would give you confidence to move forward intoP-III? Is it statistical significance on the primary endpoint? Is it directional data suggesting improvement sufficient? What can we expect to see in 1Q? Are you going to provide the six-week data for the primary endpoint, HAM-A, or will you provide efficacy data through 12 weeks? Hi, this is Sarah on for Pete. hi this is sarah on for pete Thanks for taking our questions. thanks for taking our questions Two questions from us, one on the CYB004 and the other one on the 003 program. two questions from us one on the cyb004 and the other one on the 003 program First off, around 004 and GAD, you completed enrollment in early September. first off around 004 and gad you completed enrollment in early september Congratulations on that. congratulations on that You have a readout in 1Q26 where you enrolled a total of 36 patients. you have a readout in 1q26 where you enrolled a total of 36 patients What would you like to see from this study that would give you confidence to move forward intoP-III ? what would you like to see from this study that would give you confidence to move forward intop-iii Is it statistical significance on the primary endpoint? is it statistical significance on the primary endpoint Is it directional data suggesting improvement sufficient? is it directional data suggesting improvement sufficient What can we expect to see in 1Q? what can we expect to see in 1q Are you going to provide the six-week data for the primary endpoint, HAM-A, or will you provide efficacy data through 12 weeks? are you going to provide the six-week data for the primary endpoint ham-a or will you provide efficacy data through 12 weeks

Speaker 9: I can take that one. Thank you, Sarah, for the question. Yes, we've completed enrollment in that study. As you probably know, it's a study with two arms, one low-dose arm, which potentially is subpsychedelic, and a full threshold dose. We look at that as a sort of dose-response type of study. We would love to see some separation between the two. As you stated there, directional data is what we are looking for, a trend in change or trend in separation between the two, and also within subject differences in change from baseline, at least with the threshold dose. This is a proof-of-concept study, not necessarily designed as a fully powered study. If we see a statistically significant difference, we'll be thrilled. As you say, directional data, trend in improvement, and a dose-response between the two arms is what we are looking for. I can take that one. i can take that one Thank you, Sarah, for the question. thank you sarah for the question Yes, we've completed enrollment in that study. yes we've completed enrollment in that study As you probably know, it's a study with two arms, one low-dose arm, which potentially is subpsychedelic, and a full threshold dose. as you probably know it's a study with two arms one low-dose arm which potentially is subpsychedelic and a full threshold dose We look at that as a sort of dose-response type of study. we look at that as a sort of dose-response type of study We would love to see some separation between the two. we would love to see some separation between the two As you stated there, directional data is what we are looking for, a trend in change or trend in separation between the two, and also within subject differences in change from baseline, at least with the threshold dose. as you stated there directional data is what we are looking for a trend in change or trend in separation between the two and also within subject differences in change from baseline at least with the threshold dose This is a proof-of-concept study, not necessarily designed as a fully powered study. this is a proof-of-concept study not necessarily designed as a fully powered study If we see a statistically significant difference, we'll be thrilled. if we see a statistically significant difference we'll be thrilled As you say, directional data, trend in improvement, and a dose-response between the two arms is what we are looking for. as you say directional data trend in improvement and a dose-response between the two arms is what we are looking for We will share this in first quarter. We will aim to share HAM-A data out through 12. We will share this in first quarter. we will share this in first quarter We will aim to share HAM-A data out through 12. we will aim to share ham-a data out through 12

Speaker 1: Awesome. Thanks. And then one more question from me. The P-II CYB003 data suggests that two doses may keep patients in remission for up to a year commercially. And then taking into account the psychedelic experience associated with psilocin, what do you see as the minimum durability threshold needed to compete with Spravato? And how are you thinking about the trade-off between durability versus time spent in clinics from both a payer perspective reimbursement? Awesome. awesome Thanks. thanks And then one more question from me. and then one more question from me The P-II CYB003 data suggests that two doses may keep patients in remission for up to a year commercially. the p-ii cyb003 data suggests that two doses may keep patients in remission for up to a year commercially And then taking into account the psychedelic experience associated with psilocin, what do you see as the minimum durability threshold needed to compete with Spravato? and then taking into account the psychedelic experience associated with psilocin what do you see as the minimum durability threshold needed to compete with spravato And how are you thinking about the trade-off between durability versus time spent in clinics from both a payer perspective reimbursement? and how are you thinking about the trade-off between durability versus time spent in clinics from both a payer perspective reimbursement

Speaker 9: Thanks. Thanks. thanks

Speaker 7: Okay. One moment, please, while we reconnect Dr. Amir. Okay. okay One moment, please, while we reconnect Dr. Amir. one moment please while we reconnect dr amir

Speaker 9: Can you hear me now? Sorry, I'm back. Can you hear me now? can you hear me now Sorry, I'm back. sorry i'm back

Speaker 7: Yes, sir. Now loud and clear. Yes, sir. yes sir Now loud and clear. now loud and clear

Speaker 9: Apologies for that. Can you repeat the question? Apologies for that. apologies for that Can you repeat the question? can you repeat the question

Speaker 1: The P-II CYB003 data suggests that two doses may keep patients in remission for up to a year commercially and taking into account the psychedelic experience associated with psilocin. What do you see as the minimum durability threshold needed to compete with Spravato? The P-II CYB003 data suggests that two doses may keep patients in remission for up to a year commercially and taking into account the psychedelic experience associated with psilocin. the p-ii cyb003 data suggests that two doses may keep patients in remission for up to a year commercially and taking into account the psychedelic experience associated with psilocin What do you see as the minimum durability threshold needed to compete with Spravato? what do you see as the minimum durability threshold needed to compete with spravato

Speaker 9: Yeah. I mean, when you look at the guidance that the agency provides for evaluation of these therapies, they want data up to 12 weeks, which is three months. We would be thrilled to see effects that are maintained out to three months. We are hoping for better. As you know, with our phase II data, we showed durability out to a year. Based on what is the expectation of the agency, 12 weeks at a minimum would be great. Yeah. yeah I mean, when you look at the guidance that the agency provides for evaluation of these therapies, they want data up to 12 weeks, which is three months. i mean when you look at the guidance that the agency provides for evaluation of these therapies they want data up to 12 weeks which is three months We would be thrilled to see effects that are maintained out to three months. we would be thrilled to see effects that are maintained out to three months We are hoping for better. we are hoping for better As you know, with our phase II data, we showed durability out to a year. as you know with our phase ii data we showed durability out to a year Based on what is the expectation of the agency, 12 weeks at a minimum would be great. based on what is the expectation of the agency 12 weeks at a minimum would be great

Speaker 1: All right. Thank you so much. All right. all right Thank you so much. thank you so much

Speaker 7: Thank you. Our next question will come from Patrick Trujillo with HC Wainwright. Please go ahead. Thank you. thank you Our next question will come from Patrick Trujillo with HC Wainwright. our next question will come from patrick trujillo with hc wainwright Please go ahead. please go ahead

Speaker 6: Thanks. Good morning and congrats on all the progress. I just wanted to get a clarification on the CYB004 program, just in terms of what we should expect as far as statistical powering and the definition of clinically meaningful HAM-A improvement. And then separately, I'm just wondering for CYB003, what operational milestones remain to complete enrollment and Approach and are site activations tracking the plan? Thanks. thanks Good morning and congrats on all the progress. good morning and congrats on all the progress I just wanted to get a clarification on the CYB004 program, just in terms of what we should expect as far as statistical powering and the definition of clinically meaningful HAM-A improvement. i just wanted to get a clarification on the cyb004 program just in terms of what we should expect as far as statistical powering and the definition of clinically meaningful ham-a improvement And then separately, I'm just wondering for CYB003, what operational milestones remain to complete enrollment and Approach and are site activations tracking the plan? and then separately i'm just wondering for cyb003 what operational milestones remain to complete enrollment and approach and are site activations tracking the plan

Speaker 9: Patrick, the question on CYB004. As I stated earlier, it's not a formally powered study. We would, however, be looking at an improvement from baseline within subject within the arms. A clinically meaningful effect would be somewhere around four to five points on the HAM-A. A trend to difference between the two arms would be important as well because we want to look at some dose response between the two arms. Study in the sense that it's not a pivotal study, though statistical significance would be amazing. You had a question on CYB003 as well. CYB003 is tracking as to plan. We remain on target to complete enrollment by mid of next year and deliver top-line data by the end of next year. Patrick, the question on CYB004. patrick the question on cyb004 As I stated earlier, it's not a formally powered study. as i stated earlier it's not a formally powered study We would, however, be looking at an improvement from baseline within subject within the arms. we would however be looking at an improvement from baseline within subject within the arms A clinically meaningful effect would be somewhere around four to five points on the HAM-A. a clinically meaningful effect would be somewhere around four to five points on the ham-a A trend to difference between the two arms would be important as well because we want to look at some dose response between the two arms. a trend to difference between the two arms would be important as well because we want to look at some dose response between the two arms Study in the sense that it's not a pivotal study, though statistical significance would be amazing. study in the sense that it's not a pivotal study though statistical significance would be amazing You had a question on CYB003 as well. you had a question on cyb003 as well CYB003 is tracking as to plan. cyb003 is tracking as to plan We remain on target to complete enrollment by mid of next year and deliver top-line data by the end of next year. we remain on target to complete enrollment by mid of next year and deliver top-line data by the end of next year

Speaker 6: Great. If I could, just a separate question on, as these programs are advancing into later stage and are in late-stage development, I'm just wondering what has been your engagement with payers at this stage and health economic modeling for both CYB003 and CYB004, and as well with the product profile that's emerging for both of these compounds, how you would expect positioning of them in the market relative to what's already available in TRD with Spravato, given that this is with CYB003, we're looking at MDD, CYB004, GAD. I'm just wondering how you're thinking about this early payer engagement and as well the product profile positioning against both compounds available, but also those that are in development. Great. great If I could, just a separate question on, as these programs are advancing into later stage and are in late-stage development, I'm just wondering what has been your engagement with payers at this stage and health economic modeling for both CYB003 and CYB004, and as well with the product profile that's emerging for both of these compounds, how you would expect positioning of them in the market relative to what's already available in TRD with Spravato, given that this is with CYB003, we're looking at MDD, CYB004, GAD. if i could just a separate question on as these programs are advancing into later stage and are in late-stage development i'm just wondering what has been your engagement with payers at this stage and health economic modeling for both cyb003 and cyb004 and as well with the product profile that's emerging for both of these compounds how you would expect positioning of them in the market relative to what's already available in trd with spravato given that this is with cyb003 we're looking at mdd cyb004 gad I'm just wondering how you're thinking about this early payer engagement and as well the product profile positioning against both compounds available, but also those that are in development. i'm just wondering how you're thinking about this early payer engagement and as well the product profile positioning against both compounds available but also those that are in development

Speaker 10: Hi, thanks for that, Patrick. I'll take this one. I mean, as you might imagine at this stage, it's a little bit early, but payer engagement, of course, has begun. Commenting further, I guess, on how that develops and how ultimately with Spravato, you could compare to the commercial market. Hi, thanks for that, Patrick. hi thanks for that patrick I'll take this one. i'll take this one I mean, as you might imagine at this stage, it's a little bit early, but payer engagement, of course, has begun. i mean as you might imagine at this stage it's a little bit early but payer engagement of course has begun Commenting further, I guess, on how that develops and how ultimately with Spravato, you could compare to the commercial market. commenting further i guess on how that develops and how ultimately with spravato you could compare to the commercial market

Speaker 7: All right. One moment. It looks like he has disconnected. If anybody else wants to take this question, while we reconnect him. All right. all right One moment. one moment It looks like he has disconnected. it looks like he has disconnected If anybody else wants to take this question, while we reconnect him. if anybody else wants to take this question while we reconnect him

Speaker 9: While George is dialing back in, we have been doing some preliminary market research, but as George reiterated, it is a bit early, at least for CYB004. Both the programs, we see them fitting into what is emerging now as an interventional psychiatry paradigm, which really has been spearheaded with Spravato, creating the infrastructure out there. We see these as intermittent treatments that will fit right into that model where patients come in for treatment on an intermittent basis, have the treatment in the clinic, and then return for their additional dosing as and when necessary. The infrastructure is there. We believe with the GAD for CYB004 and with adjunctive inadequate responders for CYB003, those kind of address the spectrum of the most burdensome or most resource-intensive patients that you typically see in a psychiatry practice. While George is dialing back in, we have been doing some preliminary market research, but as George reiterated, it is a bit early, at least for CYB004. while george is dialing back in we have been doing some preliminary market research but as george reiterated it is a bit early at least for cyb004 Both the programs, we see them fitting into what is emerging now as an interventional psychiatry paradigm, which really has been spearheaded with Spravato, creating the infrastructure out there. both the programs we see them fitting into what is emerging now as an interventional psychiatry paradigm which really has been spearheaded with spravato creating the infrastructure out there We see these as intermittent treatments that will fit right into that model where patients come in for treatment on an intermittent basis, have the treatment in the clinic, and then return for their additional dosing as and when necessary. we see these as intermittent treatments that will fit right into that model where patients come in for treatment on an intermittent basis have the treatment in the clinic and then return for their additional dosing as and when necessary The infrastructure is there. the infrastructure is there We believe with the GAD for CYB004 and with adjunctive inadequate responders for CYB003, those kind of address the spectrum of the most burdensome or most resource-intensive patients that you typically see in a psychiatry practice. we believe with the gad for cyb004 and with adjunctive inadequate responders for cyb003 those kind of address the spectrum of the most burdensome or most resource-intensive patients that you typically see in a psychiatry practice

Speaker 7: George has reconnected. All right. Thank you. George has reconnected. george has reconnected All right. all right Thank you. thank you

Speaker 2: Thank you. Thank you. thank you

Speaker 7: We'll go to the next question from Jim Malloy with Alliance Global Partners. Please go ahead. We'll go to the next question from Jim Malloy with Alliance Global Partners. we'll go to the next question from jim malloy with alliance global partners Please go ahead. please go ahead

Speaker 3: Hello. This is Laura Suriel on for Jim Malloy. Thank you for taking our questions. For the ongoing Approach trial, you mentioned how you're planning to have a total of 45 clinical trial sites within the U.S. Could you provide a bit more detail on the criteria behind choosing these sites and the activation process involved, as well as when you might think you have all 45 of these sites fully activated and on board for the study. Hello. hello This is Laura Suriel on for Jim Malloy. this is laura suriel on for jim malloy Thank you for taking our questions. thank you for taking our questions For the ongoing Approach trial, you mentioned how you're planning to have a total of 45 clinical trial sites within the U.S. for the ongoing approach trial you mentioned how you're planning to have a total of 45 clinical trial sites within the u.s Could you provide a bit more detail on the criteria behind choosing these sites and the activation process involved, as well as when you might think you have all 45 of these sites fully activated and on board for the study. could you provide a bit more detail on the criteria behind choosing these sites and the activation process involved as well as when you might think you have all 45 of these sites fully activated and on board for the study

Speaker 9: Yeah. I can take that. We are using a mixture of sites that are experienced in clinical trials and a smaller proportion of sites that are less experienced in psychiatry trials. We also have a mixture of sites that are experienced in conducting trials with psychedelics. There are other sites that we have included that are experienced in CNS trials in general, but not necessarily psychedelics. As you can imagine, with the number of clinical trials ongoing right now in psychedelics, there is, of course, competition for resources at sites. We have been very careful in selecting sites that, one, either have a proven track record of delivering high-quality data or, if they are not experienced in psychedelics, they have the necessary experience and expertise in the psychiatry space in general in other trials. We are confident that they will deliver good quality data. Yeah. yeah I can take that. i can take that We are using a mixture of sites that are experienced in clinical trials and a smaller proportion of sites that are less experienced in psychiatry trials. we are using a mixture of sites that are experienced in clinical trials and a smaller proportion of sites that are less experienced in psychiatry trials We also have a mixture of sites that are experienced in conducting trials with psychedelics. we also have a mixture of sites that are experienced in conducting trials with psychedelics There are other sites that we have included that are experienced in CNS trials in general, but not necessarily psychedelics. there are other sites that we have included that are experienced in cns trials in general but not necessarily psychedelics As you can imagine, with the number of clinical trials ongoing right now in psychedelics, there is, of course, competition for resources at sites. as you can imagine with the number of clinical trials ongoing right now in psychedelics, there is of course competition for resources at sites We have been very careful in selecting sites that, one, either have a proven track record of delivering high-quality data or, if they are not experienced in psychedelics, they have the necessary experience and expertise in the psychiatry space in general in other trials. we have been very careful in selecting sites that one either have a proven track record of delivering high-quality data or if they are not experienced in psychedelics they have the necessary experience and expertise in the psychiatry space in general in other trials We are confident that they will deliver good quality data. we are confident that they will deliver good quality data You referred to the number of sites. Yes, we've got 45 sites selected for this study. Virtually all of them are onboarded by now. What's important is with the number of sites that we have activated, we still remain on track to deliver or complete enrollment by mid of next year with top-line data by the end of the year. You referred to the number of sites. you referred to the number of sites Yes, we've got 45 sites selected for this study. yes we've got 45 sites selected for this study Virtually all of them are onboarded by now. virtually all of them are onboarded by now What's important is with the number of sites that we have activated, we still remain on track to deliver or complete enrollment by mid of next year with top-line data by the end of the year. what's important is with the number of sites that we have activated we still remain on track to deliver or complete enrollment by mid of next year with top-line data by the end of the year

Speaker 1: Great. Thank you. I know the current focus right now is on the CYB003 and the 004 programs. Can you just provide a bit more color on the preclinical 005 program, maybe just on the status of the preclinical studies and any potential partnership opportunities that you may be in discussions with? Great. great Thank you. thank you I know the current focus right now is on the CYB003 and the 004 programs. i know the current focus right now is on the cyb003 and the 004 programs Can you just provide a bit more color on the preclinical 005 program, maybe just on the status of the preclinical studies and any potential partnership opportunities that you may be in discussions with? can you just provide a bit more color on the preclinical 005 program maybe just on the status of the preclinical studies and any potential partnership opportunities that you may be in discussions with

Speaker 9: Yeah. For CYB005, we are doing a number of preclinical profiling studies to characterize the receptor profile, the brain penetration, as well as the primary and secondary pharmacodynamics with a range of compounds in that class, which we believe would be well suited to actually treat some of the neuropsychiatric conditions where there is significant unmet need. That work is ongoing. When there is information to share with the market, we will do so. Yeah. yeah For CYB005, we are doing a number of preclinical profiling studies to characterize the receptor profile, the brain penetration, as well as the primary and secondary pharmacodynamics with a range of compounds in that class, which we believe would be well suited to actually treat some of the neuropsychiatric conditions where there is significant unmet need. for cyb005 we are doing a number of preclinical profiling studies to characterize the receptor profile the brain penetration as well as the primary and secondary pharmacodynamics with a range of compounds in that class which we believe would be well suited to actually treat some of the neuropsychiatric conditions where there is significant unmet need That work is ongoing. that work is ongoing When there is information to share with the market, we will do so. when there is information to share with the market we will do so

Speaker 1: Understood. Thank you for taking the question. Understood. understood Thank you for taking the question. thank you for taking the question

Speaker 7: Thank you. Our next question will come from Eddie Hickman with Guggenheim. Please go ahead. Thank you. thank you Our next question will come from Eddie Hickman with Guggenheim. our next question will come from eddie hickman with guggenheim Please go ahead. please go ahead

Speaker 5: Good morning. Thank you for taking my question. Congrats on all the progress. Just two from me. How much visibility do you have into the blinded baseline patient characteristic data from the Approach study? Can you talk at all about how this patient population will differ from a TRD population as it relates to baseline? Secondly, what agreement do you have with the FDA related to the safety database for 003 and what you'll need to provide in regulatory filing? Is there a minimum number of retreatments per year needed in Extend? Thank you. Good morning. good morning Thank you for taking my question. thank you for taking my question Congrats on all the progress. congrats on all the progress Just two from me. just two from me How much visibility do you have into the blinded baseline patient characteristic data from the Approach study? how much visibility do you have into the blinded baseline patient characteristic data from the approach study Can you talk at all about how this patient population will differ from a TRD population as it relates to baseline? can you talk at all about how this patient population will differ from a trd population as it relates to baseline Secondly, what agreement do you have with the FDA related to the safety database for 003 and what you'll need to provide in regulatory filing? secondly what agreement do you have with the fda related to the safety database for 003 and what you'll need to provide in regulatory filing Is there a minimum number of retreatments per year needed in Extend? is there a minimum number of retreatments per year needed in extend Thank you. thank you

Speaker 9: Can you repeat the second question? Can you repeat the second question? can you repeat the second question

Speaker 7: Dr. Amir, you're cutting in and out. All right. Please stand by while we reconnect Dr. Amir. Dr. Amir, you're cutting in and out. dr amir you're cutting in and out All right. all right Please stand by while we reconnect Dr. Amir. please stand by while we reconnect dr amir

Speaker 9: Can you hear me now? Can you hear me now? can you hear me now

Speaker 7: Yes, sir. Now we can. Yes, sir. yes sir Now we can. now we can

Speaker 9: Yes, I can hear you. Sorry. Do you mind, Eddie, repeating that question? Yes, I can hear you. yes i can hear you Sorry. sorry Do you mind, Eddie, repeating that question? do you mind eddie repeating that question

Speaker 5: Yeah. I was asking the first question is how much visibility do you have into the blinded baseline patient characteristic data from the Approach study and how this population may differ from a TRD population? On the safety database, what you'll need in a regulatory filing? Is there a minimum number of retreatments per year needed in the Extend trial? Thanks. Yeah. yeah I was asking the first question is how much visibility do you have into the blinded baseline patient characteristic data from the Approach study and how this population may differ from a TRD population? i was asking the first question is how much visibility do you have into the blinded baseline patient characteristic data from the approach study and how this population may differ from a trd population On the safety database, what you'll need in a regulatory filing? on the safety database what you'll need in a regulatory filing Is there a minimum number of retreatments per year needed in the Extend trial? is there a minimum number of retreatments per year needed in the extend trial Thanks. thanks

Speaker 9: Yes. Thank you. The safety, as the trial is ongoing, the data is blinded. We are performing checks as necessary or as possible with blinded data, which essentially are quality checks in a blinded manner. Since this is a pivotal trial, we are, of course, being very careful with the data. There are other checks built into the database, which ensures that if there are any flags with respect to data quality, they are raised to us immediately if there is a reason for concern. So far, we have not had anything flagged in the database. We are confident that the data quality is being maintained. In terms of how this is different from the TRD population, this group of patients is earlier in the treatment cycle. Yes. yes Thank you. thank you The safety, as the trial is ongoing, the data is blinded. the safety as the trial is ongoing the data is blinded We are performing checks as necessary or as possible with blinded data, which essentially are quality checks in a blinded manner. we are performing checks as necessary or as possible with blinded data which essentially are quality checks in a blinded manner Since this is a pivotal trial, we are, of course, being very careful with the data. since this is a pivotal trial we are of course being very careful with the data There are other checks built into the database, which ensures that if there are any flags with respect to data quality, they are raised to us immediately if there is a reason for concern. there are other checks built into the database which ensures that if there are any flags with respect to data quality they are raised to us immediately if there is a reason for concern So far, we have not had anything flagged in the database. so far we have not had anything flagged in the database We are confident that the data quality is being maintained. we are confident that the data quality is being maintained In terms of how this is different from the TRD population, this group of patients is earlier in the treatment cycle. in terms of how this is different from the trd population this group of patients is earlier in the treatment cycle These are patients who are inadequately responding, and they may have failed one treatment, or they may have failed one and been on their second treatment, but not adequately responding, but not fully failed. They are not that one-third of the patient population that remains after multiple treatment trials. It is about two-thirds of, if you think of the depression population as a whole, this is the first 2/3 of those patients in the treatment cycle, whereas TRD would be the last 2/3 left after multiple treatment cycles. In terms of AIMS or safety database, the safety database really is a function of the frequency of administration. These are patients who are inadequately responding, and they may have failed one treatment, or they may have failed one and been on their second treatment, but not adequately responding, but not fully failed. these are patients who are inadequately responding and they may have failed one treatment or they may have failed one and been on their second treatment but not adequately responding but not fully failed They are not that one-third of the patient population that remains after multiple treatment trials. they are not that one-third of the patient population that remains after multiple treatment trials It is about two-thirds of, if you think of the depression population as a whole, this is the first 2/3 of those patients in the treatment cycle, whereas TRD would be the last 2/3 left after multiple treatment cycles. it is about two-thirds of if you think of the depression population as a whole this is the first 2/3 of those patients in the treatment cycle whereas trd would be the last 2/3 left after multiple treatment cycles In terms of AIMS or safety database, the safety database really is a function of the frequency of administration. in terms of aims or safety database the safety database really is a function of the frequency of administration Given that this is an intermittent treatment, what we have discussed with the agency as part of our BTD discussions is that the data that we will provide to them, the numbers that we will provide to them across the three studies would be sufficient to support an NDA. Of course, again, it depends on what we find out in the long-term extension study with respect to treatment frequency. Given that this is an intermittent treatment, what we have discussed with the agency as part of our BTD discussions is that the data that we will provide to them, the numbers that we will provide to them across the three studies would be sufficient to support an NDA. given that this is an intermittent treatment what we have discussed with the agency as part of our btd discussions is that the data that we will provide to them the numbers that we will provide to them across the three studies would be sufficient to support an nda Of course, again, it depends on what we find out in the long-term extension study with respect to treatment frequency. of course again it depends on what we find out in the long-term extension study with respect to treatment frequency

Speaker 5: Great. Thank you so much. Great. great Thank you so much. thank you so much

Speaker 9: Sure. Sure. sure

Speaker 7: Thank you. Our next question will come from Elemor Piros with Lucid Capital Partners. Please go ahead. Thank you. thank you Our next question will come from Elemor Piros with Lucid Capital Partners. our next question will come from elemor piros with lucid capital partners Please go ahead. please go ahead

Speaker 8: Yes. Thank you. I just wanted to get maybe just one tiny detail on the loan repayment. If you could clarify how much was repaid and what was the prepayment penalty or the early repayment fees. Yes. yes Thank you. thank you I just wanted to get maybe just one tiny detail on the loan repayment. i just wanted to get maybe just one tiny detail on the loan repayment If you could clarify how much was repaid and what was the prepayment penalty or the early repayment fees. if you could clarify how much was repaid and what was the prepayment penalty or the early repayment fees

Speaker 10: Thank you. Yes. We repaid High Trail $20 million, and the repayment fee ended up being 10%. Thank you. thank you Yes. yes We repaid High Trail $20 million, and the repayment fee ended up being 10%. we repaid high trail $20 million and the repayment fee ended up being 10%

Speaker 8: 10%. It wasn't a $50 million loan? Just. 10%. 10% It wasn't a $50 million loan? it wasn't a $50 million loan Just. just

Speaker 10: Yes. The loan was structured as a convertible debt, and they had converted the other $30 million, approximately. Yes. yes The loan was structured as a convertible debt, and they had converted the other $30 million, approximately. the loan was structured as a convertible debt and they had converted the other $30 million approximately

Speaker 8: They converted the other. Okay. Okay. That's all. Thank you so much. They converted the other. they converted the other Okay. okay Okay. okay That's all. that's all Thank you so much. thank you so much

Speaker 10: You're very welcome. You're very welcome. you're very welcome

Speaker 7: Thank you. Our next question will come from Samant Kulkarni with Canaccord Genuity. Please go ahead. Thank you. thank you Our next question will come from Samant Kulkarni with Canaccord Genuity. our next question will come from samant kulkarni with canaccord genuity Please go ahead. please go ahead

Speaker 4: Good morning. Nice to see the progress, and thanks for taking our questions. I have three. On CYB003, during your pivotal trial program, how important is it that patients remain compliant with their background antidepressant use? Good morning. good morning Nice to see the progress, and thanks for taking our questions. nice to see the progress and thanks for taking our questions I have three. i have three On CYB003, during your pivotal trial program, how important is it that patients remain compliant with their background antidepressant use? on cyb003 during your pivotal trial program how important is it that patients remain compliant with their background antidepressant use

Speaker 7: All right. One moment, please. All right. all right One moment, please. one moment please

Speaker 9: Sorry. I was speaking on mute, Samant, taking that question. For our patients in the Approach study and Embrace, because this is adjunctive, the instructions to the patients and requirements in the protocol is that they remain on their background antidepressant medication. We do not expect them or advise them to come off their antidepressant medication during the treatment period. Sorry. sorry I was speaking on mute, Samant, taking that question. i was speaking on mute samant taking that question For our patients in the Approach study and Embrace, because this is adjunctive, the instructions to the patients and requirements in the protocol is that they remain on their background antidepressant medication. for our patients in the approach study and embrace because this is adjunctive the instructions to the patients and requirements in the protocol is that they remain on their background antidepressant medication We do not expect them or advise them to come off their antidepressant medication during the treatment period. we do not expect them or advise them to come off their antidepressant medication during the treatment period

Speaker 4: Got it. On 004, do you see an eventual pivotal program involving an intramuscular route of delivery? What are some of the key challenges with developing an oral formulation? My last question is, what are some of the specific qualities that you believe are must-haves for an incoming CEO? Got it. got it On 004, do you see an eventual pivotal program involving an intramuscular route of delivery? on 004 do you see an eventual pivotal program involving an intramuscular route of delivery What are some of the key challenges with developing an oral formulation? what are some of the key challenges with developing an oral formulation My last question is, what are some of the specific qualities that you believe are must-haves for an incoming CEO? my last question is what are some of the specific qualities that you believe are must-haves for an incoming ceo

Speaker 9: I can take the first two. Eric can take the last one. Right now, yes, intramuscular is the route of administration that we plan to progress in phase III. It's a very convenient form of administration, which also gives us what we need in terms of the plasma exposures and the acute experience, which cannot be achieved with something like oral. With oral, the elimination is pretty rapid. DMT or CYB004 does not reach the plasma PK levels, the threshold that is necessary for a breakthrough experience, which, as we know, is necessary for therapeutic efficacy. That we are achieving with intramuscular, it's well tolerated. That is what we are going to take into phase III. I can take the first two. i can take the first two Eric can take the last one. eric can take the last one Right now, yes, intramuscular is the route of administration that we plan to progress in phase III. right now yes intramuscular is the route of administration that we plan to progress in phase iii It's a very convenient form of administration, which also gives us what we need in terms of the plasma exposures and the acute experience, which cannot be achieved with something like oral. it's a very convenient form of administration which also gives us what we need in terms of the plasma exposures and the acute experience which cannot be achieved with something like oral With oral, the elimination is pretty rapid. with oral the elimination is pretty rapid DMT or CYB004 does not reach the plasma PK levels, the threshold that is necessary for a breakthrough experience, which, as we know, is necessary for therapeutic efficacy. dmt or cyb004 does not reach the plasma pk levels the threshold that is necessary for a breakthrough experience which as we know is necessary for therapeutic efficacy That we are achieving with intramuscular, it's well tolerated. that we are achieving with intramuscular it's well tolerated That is what we are going to take into phase III. that is what we are going to take into phase iii

Speaker 2: Maybe I can also add in here that the intramuscular route is one that, as we are aware from our market research with the interventional psychiatry clinics, is one that is also being used currently by interventional psychiatrists administering ketamine. That gives us some confidence that it is a route that will reach adoption in the market. Maybe I can also add in here that the intramuscular route is one that, as we are aware from our market research with the interventional psychiatry clinics, is one that is also being used currently by interventional psychiatrists administering ketamine. maybe i can also add in here that the intramuscular route is one that as we are aware from our market research with the interventional psychiatry clinics is one that is also being used currently by interventional psychiatrists administering ketamine That gives us some confidence that it is a route that will reach adoption in the market. that gives us some confidence that it is a route that will reach adoption in the market With regard to your question regarding CEO qualities, I mean, obviously, we've been at it for only about eight weeks right now. The board is spearheading that process. At the moment, we're looking for the qualities that this company and its shareholders deserve: a successful steward of capital that investors can feel confident in, someone that has executed in the past, bringing a novel drug to market, ideally through commercialization, an individual that has transacted and dealt with big pharma in the past as well. These are all table stakes for us and the next individual that will be sitting in the chair. With regard to your question regarding CEO qualities, I mean, obviously, we've been at it for only about eight weeks right now. with regard to your question regarding ceo qualities i mean obviously we've been at it for only about eight weeks right now The board is spearheading that process. the board is spearheading that process At the moment, we're looking for the qualities that this company and its shareholders deserve: a successful steward of capital that investors can feel confident in, someone that has executed in the past, bringing a novel drug to market, ideally through commercialization, an individual that has transacted and dealt with big pharma in the past as well. at the moment we're looking for the qualities that this company and its shareholders deserve a successful steward of capital that investors can feel confident in someone that has executed in the past bringing a novel drug to market ideally through commercialization an individual that has transacted and dealt with big pharma in the past as well These are all table stakes for us and the next individual that will be sitting in the chair. these are all table stakes for us and the next individual that will be sitting in the chair

Speaker 4: Got it. Thank you. Got it. got it Thank you. thank you

Speaker 7: Thank you. At this time, there are no further questions in the queue. I would like to turn the call back over to Eric for any additional or closing remarks. Thank you. thank you At this time, there are no further questions in the queue. at this time there are no further questions in the queue I would like to turn the call back over to Eric for any additional or closing remarks. i would like to turn the call back over to eric for any additional or closing remarks

Speaker 2: No further remarks. I just want to thank everybody for attending the call today. It's been a very exciting time for Cybin, and we look forward to delivering some fantastic updates for everybody in the future. Thank you all for your support. No further remarks. no further remarks I just want to thank everybody for attending the call today. i just want to thank everybody for attending the call today It's been a very exciting time for Cybin, and we look forward to delivering some fantastic updates for everybody in the future. it's been a very exciting time for cybin and we look forward to delivering some fantastic updates for everybody in the future Thank you all for your support. thank you all for your support

Speaker 7: Thank you, ladies and gentlemen. This does conclude today's program, and we appreciate your participation. You may disconnect at any time. Thank you, ladies and gentlemen. thank you ladies and gentlemen This does conclude today's program, and we appreciate your participation. this does conclude today's program and we appreciate your participation You may disconnect at any time. you may disconnect at any time