Cybin Inc.

Good morning and thank you for joining the Sibon Second Quarter 2026 Financial Results and Corporate Update Call. As a reminder, our press release detailing today's updates is available in the Investors section of our website. On today's call, you will first hear from Eric So, Sibon's Interim Chief Executive Officer and Executive Chair. Following Eric's remarks, Amir Inimdar, CYBIN's Chief Medical Officer, will provide an update on our lead programs CYB003 and CYB004. Finally, Greg Cavers, CYBIN's Chief Financial Officer, will review the financials. Eric will then return with closing comments before we open the lines for Q&A. Before we get started today, I would like to remind everyone that certain statements in this update are forward-looking statements and are perspective in nature. In preparing these forward-looking statements, several assumptions were made by SIBIN, and there are risks that actual results obtained by the company will differ materially from these statements. The company cannot guarantee that any forward-looking statement will materialize, and you are cautioned not to place undue reliance on them. We refer current and potential investors to the forward-looking information sections of the company's management discussion and analysis available at feederplus.ca and on EDCIR at sec.gov. Forward-looking statements represent SIBIN's expectations as of November 13, 2025. Except as required by securities laws, SIBIN does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. I will now turn the call over to Eric for his introductory remarks.

Good morning, and thank you for joining us. This is an important quarter for Siben, one that sets the stage for an active year of milestones. In September, Doug Drysdale stepped down as Chief Executive Officer. On behalf of the Board and the company, I want to thank Doug for his contributions. As co-founder and executive chair, I stepped in as interim CEO to lead the transition while maintaining continuity and momentum. The Board's search for a permanent CEO is underway. Through this transition, our priorities remain the same. patient-focused rigorous science, disciplined execution, and clear communication. We have tightened operational cadence and disclosure discipline, and we'll be adding targeted talent and scientific advisory board expertise to support late-stage execution and launch readiness. Our strategy starts where care happens, in the clinic. What I mean by this is that we are designing therapy days that fit within existing schedules with short, predictable sessions and a staff-light workflow that clinic teams can run without new infrastructure. From there, our focus turns to maintaining wellness. Durability is built into the plan with an efficient retreatment approach that aims to reduce visit burden compared with today's multidisciplinary standards so clinics can scale capacity and patients can plan their lives. Progress with regulators follows the same discipline. We move step-by-step, anchored in data rather than speculation, and we'll communicate milestones as they are achieved. The capital plan matches that pace. Following our recent $175 million financing, we are focusing on advancing our programs towards major data readouts. With that context, let me turn to the quarter and the progress we've made. Before we proceed to the agenda, a brief overview of our pipeline. For those of you who are new to the side and story, we have two lead programs. Side 003, our proprietary deuterated psilocin analog, is in phase three studies for potential adjunctive treatment of major depressive disorder. And side 004, our deuterated dimethyltryptamine, or DMT program, for the potential treatment of generalized anxiety disorder, is in phase two. Clinically, our Phase III SIDE003 program, which has been giving breakthrough therapy designation in major depressive disorder, has continued to progress, including being granted additional clearances to commence EMBRACE, our second Phase III study, and new geographies. In generalized anxiety disorder, the Phase II SIDE004 study completed enrollment and remains on track for our first calendar quarter 2026 top-line readout. Amir will share more details about both programs shortly. At the same time, we advance preparations for scale, including manufacturing and commercial groundwork aligned to a practical clinic workflow. We also strengthen our capital position with the closing of a significant registered direct offering, which provides flexibility to execute through upcoming milestones with clear internal decision gates by program. Across both programs, we are deploying capital with discipline. We are prioritizing global site activation and conduct for embrace and approach, database lock and analysis for side 004, and manufacturing readiness for side 003. With that framework in mind, I'd like to turn the call over to our Chief Medical Officer, Amir Memdar, to review our clinical and regulatory process. He'll begin with SIDE003 and major depressive disorder, focusing on that study status, global footprints, and how the design supports real-world clinic operations and durable outcomes. Dr. Amandar will then review SIDE004 and generalized anxiety disorder, including trial design, operational status following enrollment completion, and the timing and scope of the next data update.

Thank you, Eric. Our Phase III paradigm program is moving forward as planned. Dosing is underway in approach across US sites and participants have rolled over into extent to generate durability data once the double blind period concludes. In parallel, EMBRACE has been cleared to commence in the United States, UK, multiple countries in the European Union and Australia, giving us a truly global footprint. The study targets approximately 330 participants cross about 60 clinical sites and is structured with three arms to evaluate two active doses against placebo in patients with depression whose symptoms remain inadequately controlled on background therapy. The primary endpoint is the change from baseline in Madras total score at six weeks after the first dose. The design is built for clinical reality. TYB003 is intended to run as a predictable staff light session that fits within existing clinic infrastructure. Prior clinical data showed sustained response and remission at 12 months after two 16 milligram doses. And our extension work is aimed at translating that durability into an efficient re-treatment approach that reduces visit burden compared with today's multi-visit standards. On the regulatory front, A posture remains conservative and specific. Near-term touchpoints focus on clean study conduct, global site activation, and data quality reviews as we advance towards pivotal readouts. In anxiety, the work is tracking on schedule. We have completed enrollment in the randomized double-blind phase two study of CYB004 and remain on track for top-line data in the first calendar quarter of 2026. The study evaluates two intramuscular doses given three weeks apart with efficacy assessed at 6 and 12 weeks and optional follow-up out to 12 months. The design permits concomitant antidepressants or anxiolytics and allows comorbid depression, which helps the results reflect real clinical populations. Just as important, Intramuscular administration supports short, predictable sessions that fit a standard clinic day so sites can manage throughput with existing rooms and personnel. The protocol also captures information to guide an efficient retreatment approach if patients need it, aligning durability with practical clinic operations. I will now turn the call back to Eric to discuss the platform and commercial readiness.

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 OzMind, 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 and 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 2, side 003 data showed sustained response and remission at 12 months after just two doses. And 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 SIBEN. The financing provides the resource to advance our ongoing Phase 2 and Phase 3 trials towards key data readouts, We have used a portion of the net proceeds from the financing to repay the outstanding convertible debentures to Hytrail. 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 side 003, funds support global phase three execution and manufacturing readiness so sites have reliable supply and predictable therapy days. For side 004, resources move 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 flexibility. 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 then 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 30, 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 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, 28.9 million and net loss for the quarter was 33.7, 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 side 003, we will continue dosing and approach and expand embrace site activation across clear geographies, keeping study conduct and data quality at the center of the plan as we progress towards a phase three top line in Q4 of 2026. For side 004, 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 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 delivery clean 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 1 keys on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. Once again, that is star 1 to ask a question. And we'll 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 side 004 and the other one on the 003 program. First off, around 004 and GAD, you completed enrollment in early September. Congratulations on that. And 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 into P3s? Is it statistical significance on the primary endpoint? Is it directional data suggesting improvement sufficient? And then what can we expect to see in one queue? 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. And 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 state, the 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, but if we see a statistically significant difference, we'll be thrilled. But as you say, directional data, trend and improvement, and a dose response between the two arms is what we are looking for. We'll share this in first quarter. We will aim to share HAMI data out through 12...

Awesome, thanks. And then one more question from me. The P27003 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 from both a payer perspective reimbursement.

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. Um, can you repeat the question?

Um, the P two Simon zero zero three 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 Sullivan. Like what do you see as the minimum durability threshold needed to compete with bravado?

Yeah. 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 will be thrilled to see effects that are maintained out to three months. We are hoping for better. As you know, with our phase two data, we showed durability out to a year. But 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 Trucchio with HC Wainwright. Please go ahead.

Thanks. Good morning and congrats on all the progress. I just wanted to get a clarification on the CYB4 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 CYB3, what operational milestones remain to complete enrollment and approach? And are site activations tracking the plan?

CYB4? As I stated earlier, it's not a formally powered study. We would, however, be looking at 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. In the sense that it's not a pivotal study, those statistical significance would be amazing. you had a question on cyb3 as well cyb3 is tracking uh as as to plan so we remain on target to complete enrollment by mid of next year and deliver top line data by the end of next year

Great. And if I could, just a separate question on, you know, 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 CYB3 and CYB4, 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 CYB3, we're looking at MDD. CYB4 GAD. But I'm just wondering how you're thinking about, you know, this early payer engagement and as well the product profile positioning against, you know, both compounds available, but also those that are in development.

Hi. Thanks for that, Patrick. I'll take this one. So, I mean, as you might imagine at this stage, you know, it's a little bit early, but payer engagement, of course, has begun. Commenting further, I guess, on, you know, how that develops and how ultimately with Bravato 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 it.

So while George is dialing back in, so we have been doing some preliminary market research, but as George reiterated, it is a bit early for at least for CYB4. 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... on an intermittent basis, have the treatment in the clinic, and then return for the additional dosing as and when necessary. The infrastructure is there. And we believe with GAD for CYB4 and with adjunctive in inadequate responders for CYB3, those kind of address the spectrum of the most burdensome or most resource-intensive patients that you typically see in a psychiatry practice.

And George has reconnected. All right, thank you.

You may have covered it well. Thank you.

We'll go to the next question from Jim Molloy with Alliance Global Partners. Please go ahead.

Hello, this is on for Jim Molloy. Thank you for taking our questions. So for the ongoing approach trial, you mentioned how you're planning to have a total of 45 clinical trial sites within the U.S. So you may provide a bit more detail on the criteria behind choosing these sites and the activation process involved, and also as well as when you might think you have all 45 of these sites fully activated and on board for the study. Okay.

Yeah, so I can take that. So 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. And then 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's of course competition for resources at sites and we've been very careful in selecting sites that one, either have a proven track record of delivering high quality data or have the, if they're not experienced in psychedelics, they have the necessary experience and expertise in the psychiatry space in general, in other trials, and 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 our complete enrollment by mid of next year with top line data by the end of the year.

Great. Thank you. And then also, I know the current focus right now is on the CYB-003 and the 004 programs, but 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?

For CYP005, 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. So that work is ongoing, and when there is information to share with the market, we will do so.

Understood. Thank you for taking the questions.

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 for me. How much visibility do you have into the blinded baseline patient characteristic data from the approach study? And can you talk at all about how this patient population will differ from a TRD population as it relates to baseline? And secondly, what agreement do you have with the FDA related to the safety database for 003 and what you'll need to provide a regulatory filing? Is there a minimum number of re-treatments per year needed in Xtend? 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 any repeating that question?

Yeah, so I was asking the first question is how much visibility do you have into the blinded baseline patient characteristics data from the approach study and how this population may differ from a TRD population? And then 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. Uh, so, um, the safety as, as the trial is ongoing, the data is blinded. We are performing checks as necessary or as, as possible with blinded data, which essentially are quality checks in a blinded manner. Um, And 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 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 haven't had anything flagged in the database. So we are confident that the data quality is being maintained. In terms of how this is different from the TRD population, so this group of patients is earlier in the treatment cycle. So 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's about two-thirds. If you think of the depression population as a whole, this is the first two-thirds of those patients in the treatment cycle, whereas TRD would be the last two-thirds left after multiple treatment cycles. in terms of ends the uh or safety database the safety database really is a function of the frequency of administration um 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 provide to them across the three studies would be sufficient to support an NDA, but 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.

Thank you. Our next question will come from Elmer 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%.

So it wasn't a $50 million loan?

Yes, the loan was structured as a convertible debt, and they had converted the other $30 million.

Approx. Okay, okay. Well, that's all, and thank you so much. You're very welcome.

Thank you. Our next question will come from Sumant Kulkarni with Canaccord Genuity. Please go ahead.

Good morning. Nice to see the progress, and thanks for taking our questions. I have three. On CYV003, 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, so I'm taking that question. So 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 medications. And we do not expect them or advise them to come off their antidepressant medication during the treatment period.

Got it. And then on 004, do you see an eventual pivotal program involving an intramuscular route of delivery? And what are some of the key challenges with developing an oral formulation? And 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 3. 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 the elimination is pretty rapid and DMT or CYB4 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. So that is what we are going to take into phase three.

And maybe I can also add in there 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. And so that gives us some confidence that it is a route that will reach adoption in the market.

And with regard to your question regarding CEO qualities, I mean, obviously, you know, we've been at it for only about eight weeks right now. The board is, you know, spearheading that process. And at the moment, you know, we're looking for the qualities that this company and its shareholders deserve. You know, 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, so I'd 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 Simon, 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.