Q2 2026 Cybin Inc Earnings Call
Speaker #1: thank you for joining the CYBIN second quarter 2026 call. As a financial results and corporate update Good morning and reminder, our press release detailing website.
Speaker #1: On today's call, you will hear from Soh, CYBIN's interim chief executive officer and executive medical officer. We will provide an update on our lead program, CYB003, and remarks from Amir Inamdar, CYBIN's chief... investor section of our... Finally, Greg Cavers will first hear from Eric before we open the lines for Q&A.
Speaker #1: Before we get everyone that certain statements in this update started today, I would like to remind chair; following Eric's are forward-looking statements and review the CYBIN's chief financial officer; we'll are prospective in nature.
Speaker #1: statements, several assumptions were made by financials. Eric will then return with closing comments CYBIN, and there are risks that actual materially from these statements.
Speaker #1: results obtained by the company will differ materialize, and you are cautioned not that any forward-looking statement will The company cannot guarantee potential investors to the forward-looking to place undue reliance on information sections of the company's management them.
Speaker #1: discussion and analysis available at cedarplus.ca and on Edgar at sec.gov. Forward-looking statements represent CYBIN's 2025. Except as required by securities We refer current and expectations as of November 13, new information, future events, any obligation to update any or otherwise.
Speaker #1: I will executive chair, I stepped in as remarks.
Speaker #2: Good This is an important quarter for CYBIN, one that sets the stage for an active year of September, Doug Drysdale stepped down as chief
Speaker #2: Good This is an important quarter for CYBIN, one that sets the stage for an active year of
Speaker #2: CEO is underway. Through this programs towards major data scale capacity and patients can plan their made. Before we proceed to the agenda, a infrastructure.
Speaker #2: predictable sessions and a multi-visit standards so clinics can durability as built into the plan, with an discipline. We move step by step, anchored in clinic.
Speaker #2: due-to-rated silicon analog, is a phase three study in new CYB003, our proprietary clearances to commence Embrace, our second geographies. In generalized anxiety From there, we focus our focus remains on track for our first calendar quarter of study completed enrollment and readout.
Speaker #2: dimethyltryptamine, or DMT, program potential adjunctive treatment of major depressive those of you who are new to the CYBIN story, we disorder. And CYB003 program, which has been depressive disorder, has continued to progress, brief overview of our pipeline.
Speaker #2: shortly. At the same time, we advance preparations details about both programs For 2026 top-line also strengthen our capital position with the commercial groundwork aligned to a offering which provides flexibility to Amir will share more execute through upcoming milestones with clear internal decision gates by deploying capital with discipline.
Speaker #2: are prioritizing global site program. We Across both programs, we are analysis for CYB004, and manufacturing readiness for CYB003. With that framework in approach, database lock and for scale, including manufacturing and process.
Speaker #2: He'll begin with CYB003 and major depressive disorder, to review our clinical and regulatory focusing on that study status, global footprint, and how the design supports real-world clinic operations and durable review CYB004 and outcomes.
Speaker #2: including trial design, operational the timing and scope of the next data status following enrollment completion, and generalized anxiety disorder,
Speaker #3: Eric. Our phase three paradigm, the study Australia, gives us a truly global target of approximately 330 participants across about 60 clinical sites. It is structured with three arms to evaluate two active doses against placebo in patients with depression, who are controlled on background MADRS total score at six weeks of therapy.
Speaker #3: program is moving forward as update.
Speaker #3: generate durability data once Thank you, 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 Dr. Inamdar will then footprint.
Speaker #3: after the first dose. endpoint is the change from baseline in reality. The primary CYB003 is intended to run as a symptoms remain inadequately predictable staff-like session that fits within existing clinic infrastructure.
Speaker #3: After the first dose, the endpoint is the change from baseline in reality. The primary CYB003 is intended to run as a symptoms remain inadequately predictable, staff-like session that fits within existing clinic design. The design is built for clinical trials. Prior clinical data showed sustained response and remission at 12 months after two 16-milligram doses.
Speaker #3: And our extension work is durability into an efficient retreatment aimed at translating that the regulatory front, a burden compared with today's multi-visit standards. posture remains conservative and On specific.
Speaker #3: Near-term touch points focus on clean study conduct, global site activation, and data quality reviews as we advance towards pivotal approach that reduces visit readouts.
Speaker #3: In schedule. We have completed enrollment in the randomized double-blind phase two study of CYB004 and remain on track for of top-line data in the first calendar quarter 2026.
Speaker #3: Anxiety, the work is tracking on. The study evaluates two intramuscular doses given three weeks apart, with efficacy assessed at six and 12 weeks, and optional follow-up up to 12 months.
Speaker #3: 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 fit a standard clinic day, so short, predictable sessions that existing rooms and personnel.
Speaker #3: Sites can manage throughput with the protocol. It also captures information to guide an efficient treatment and retreatment approach if patients need it, aligning durability with practical clinic operations.
Speaker #3: I will now turn the call back to Eric to discuss the platform and commercial
Speaker #3: readiness.
Speaker #2: Thank
Speaker #2: you, Amir. Our focus is to make these therapies workable in the real world, not just on paper. Achieving that With thermal fissure in place for both drug goal begins with dependable supply.
Speaker #2: substance and capsule drug product in the United States, we have a manufacturing footprint sized for phase three and commercialization. Which gives sites the predictability to plan therapy days within their existing four walls.
Speaker #2: From there, we extend into the clinic. Through our partnership with Osmind, we have access practices, point-of-care software, to a broad network of psychiatric and real-world data.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: CYB004, delivered 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.
Speaker #2: Durability is the other half of practicality. Phase showed sustained response and remission at 12 months after just two doses. And our extension work is there to two CYB003 data translate that durability into an efficient retreatment approach.
Speaker #2: is fewer visits and more efficient planning for clinics and payers alike with clear criteria for when patients The goal should return. How long a session should take, and how that fits across a full clinic day.
Speaker #2: a conservative regulatory posture and a disciplined capital plan. We're advancing this platform with Underpinning it all is steady leadership. We manage the CEO transition and orderly way.
Speaker #2: 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.
Speaker #2: Before I turn the call over to Greg Cabers, our CFO, let me touch on our capital structure. Last month, we closed a registered direct offering with institutional healthcare investors.
Speaker #2: The structure paired common shares with partial warrants, aligning capital to participation from prominent near-term objectives and giving us the flexibility to execute. As noted earlier, this was an important step for Cybin.
Speaker #2: The financing provides the resource to advance our ongoing phase two and phase three trials towards key data readouts. We have used a portion of the net proceeds from the financing to repay the outstanding convertible dimensions to high trail, for the avoidance of any doubt this debt has been fully retired in full.
Speaker #2: 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.
Speaker #2: came into this financing and all prior financings that drive our program forward. Capital We could not be happier with the partners that deployment is paced to measurable milestones.
Speaker #2: CYB003, funds support global phase three execution and manufacturing readiness, For so sites have reliable supply and predictable therapy days. For CYB004, resources move to database lock, protocol specified analyses, and operational lift to top line.
Speaker #2: use remains limited and targeted. The planned bridges us to the next two major data Corporate 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.
Speaker #2: I will now hand it off to Greg Cabers, our CFO, to walk through our second quarter financial
Speaker #3: Thank you, Eric.
Speaker #3: During the quarter, cash-based operating expenses consisting of results. 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: loss was $28.9 Operating 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.
Speaker #3: We ended the quarter with cash, cash equivalents, and investments of $83.8 end, we closed the financing of $175 million. Subsequent to quarter million which together with our quarter end balance provides flexibility to execute our plan.
Speaker #3: We continued 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.
Speaker #3: 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 and approach and expand site activation across clear geographies, keeping study conduct and data quality at the center of the plan as we progress towards a Phase 3 top line in Q4 of 2026.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: This forward plan also includes leadership. The CEO search is active and progressing, and we'll provide an update when there is stable under the current structure with operating news.
Speaker #2: intact. Taken cadence and disclosure discipline 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 Day-to-day execution remains follow.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: Of our employees, investigators, investors, partners, and most importantly, the patients, I want to thank all the families who make this progress possible. We look forward to updating you as we meet our milestones.
Speaker #2: Operator, please open the phone line for
Speaker #2: questions. Yes,
Speaker #4: 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.
Speaker #4: Once again, that is star one to ask a question, and we'll take our first question from Pete Stavropulos with Cantor Fitzgerald. Please go ahead.
Speaker #5: 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.
Speaker #5: First off, around 004 and GAD, you completed enrollment and early September. Congratulations on that. And you have a readout in 1Q26 where you enrolled a total of 36 patients.
Speaker #5: 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?
Speaker #5: Is it directional data suggesting improvement sufficient? And then what can we expect to see in 1Q? Are you going to provide the six-week data for the primary endpoint, Hame, or will you provide efficacy data through 12
Speaker #5: Is it directional data suggesting improvement sufficient? And then what can we expect to see in 1Q? Are you going to provide the six-week data for the primary endpoint, Hame, or will you provide efficacy data through 12 weeks?
Speaker #6: 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
Speaker #1: Sort of dose response type of study . We would some love to see separation the two between As you stayed there . Directional data is what we are looking for .
Speaker #1: A trend in change or separation between the two , and also within subject differences in change trend in from baseline . At least with the threshold dose .
Speaker #1: This is a proof of concept study , not necessarily designed as a fully study , but if a we see statistical significance statistically significant difference will be thrilled .
Speaker #1: But say , directional data trend in improvement and a dose as you response between the are looking two arms is what we for .
Speaker #1: And we'll share this in the first quarter. We will aim to share Ham data out through 12.
Speaker #2: Awesome . Thanks . And then one more question from me . The P-2 Sabin 003 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 see as the minimum , what do you durability threshold needed to compete with Spravato ?
Speaker #2: 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 a perspective , reimbursement .
Speaker #3: Piece .
Speaker #4: Okay , one moment please . While we reconnect , Doctor Amir .
Speaker #1: Can you hear back me now ?
Speaker #4: sir . Now , loud and
Speaker #4: .
Speaker #1: that .
Speaker #1: repeat the question Yes , Apologies for ?
Speaker #2: The P2 Sabin 003 . Data suggests that two doses may keep patients in remission for up to year commercially , and taking account the psychedelic experience into associated with psilocin .
Speaker #2: what do you Like , see as the minimum durability threshold needed to compete with Spravato ?
Speaker #1: Yeah , I mean , when you look at the guidance that the agency provides for for evaluation of these therapies , they want data to 12 weeks , which is three months .
Speaker #1: 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 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 .
Speaker #2: All right . Thank you so much .
Speaker #4: Thank you . Our next question will come from Patrick Trujillo with HC Wainwright . Please go ahead .
Speaker #5: Thanks . Good morning and congrats on all the progress . I just wanted to a clarification on the SIB for program . Just in terms of what we should as far as statistical powering and the get definition of clinically expect meaningful .
Speaker #5: Him a improvement . And then separately , I'm just wondering CIB three , for operational what remain to complete enrollment in approach . And our site tracking the plan milestones .
Speaker #5: activations
Speaker #1: Patrick . Before , as I stated earlier , it's not a formally powered study . would , however , be looking We at a improvement in from baseline within subject within the arms .
Speaker #1: A clinically meaningful effect would be somewhere around 4 to 5 points on the HAM-A. A difference between the two arms would be trend to important as well, because we want to look at some dose response between the two arms.
Speaker #1: Study in sense that it's not a pivotal study . Those significance would be amazing . You had a question on CIB well three as .
Speaker #1: Seb three is tracking 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 .
Speaker #5: Great . And could just a separate question on , you know , as these programs are , you advancing into later stage and stage development , I'm just or in late wondering what has been your engagement with what payers at this stage ?
Speaker #5: And , you know , health , economic modeling for CIB three and both CIB four and as well with the product profile that's emerging for both of these compounds , how you would expect positioning of them in the , you know , in the market relative to what's already available , you know , in in you know , TRD with Spravato , you know , given that this is you know , with Seb we're three , looking at MDD , Seb for Gad .
Speaker #5: But I'm just wondering how you're thinking about , you know , this early payer as well the product profile positioning engagement and against both compounds available but also those that are in development .
Speaker #6: Hi . Thanks for that I'll take this one . So I mean , as you might imagine , at this Patrick . stage it's a little bit early , but payer engagement of course has has begun .
Speaker #6: Commenting further I guess on , you know , how that develops and how ultimately with Spravato , you could you could compare the commercial models .
Speaker #4: It All right . looks One like he disconnected . If has anybody else wants to take this question while we reconnect him .
Speaker #1: while So is George dialing back in . So we have been doing some market research . But as George reiterated , it is a bit early for at least for Seb , for us and both the programs we see them fitting into what is emerging now as an interventional psychiatry paradigm , which really has been spearheaded Spravato with the infrastructure out there .
Speaker #1: 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 their additional dosing as and when necessary .
Speaker #1: The infrastructure is there and we believe with the Gad for Seb for and with with adjunctive in inadequate responders for Seb three , those kind of address the the spectrum of the most burdensome or most resource intensive patients that you typically see in a psychiatry practice .
Speaker #4: And George has reconnected . All right .
Speaker #6: Thank you . Thank you .
Speaker #4: We'll go to the next question from Jim Malloy with Alliance Global Partners . Please go ahead .
Speaker #7: Hello . This is Laura on for Jim Malloy . Thank you for taking our questions . So for the on going approach trial , you mentioned how you're planning to have a total of 45 clinical trial sites within the US .
Speaker #7: 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 you might think have all 45 of these sites fully activated and on board for the study .
Speaker #1: Yeah . So I can take that . So we are using a mixture of sites are experienced in clinical trials and a smaller proportion of sites that are less experienced in psychiatry trials .
Speaker #1: We have a also mixture of sites that are experienced in conducting stars 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 , course there's of competition for resources at sites .
Speaker #1: And we've 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 in the psychiatry space in general .
Speaker #1: In other trials . And we are confident that they will deliver good quality data . You refer to the number of sites . Yes , we've got 45 .
Speaker #1: Sites selected for this study . Virtually all of them are on boarded up now by . What's important is with the number sites that we have of 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 #7: Great . Thank you . And then also , I know the current focus right now is on the side oh three and the oh four programs , just but can you provide a bit more color on the preclinical 005 program ?
Speaker #7: Maybe just on the status of preclinical studies and any the partnership opportunities that you may be in discussions with ?
Speaker #1: Yeah , for CB oh five , 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 in that class , which we believe would be well suited to actually some of treat the neuropsychiatric conditions where there is significant unmet need .
Speaker #1: So that work is ongoing when . And there is information to share with the market , we will we will do so .
Speaker #7: Understood . Thank you for taking the questions
Speaker #7: .
Speaker #4: Thank you. Our next question will come from Eddie Hickman with Guggenheim. Please go ahead.
Speaker #8: Good morning . taking my Thank you for question . Congrats on all the progress . me . Just two for How much visibility have into the do you blinded base baseline patient characteristics data from the approach study .
Speaker #8: 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 in regulatory filing ?
Speaker #8: Is there a minimum number of year needed in Retreatments per extend ? Thank you .
Speaker #3: Yeah .
Speaker #1: I . Can you repeat the second question ? Can you .
Speaker #4: Doctor Amir , you're cutting in and out . All right . by while Please stand we reconnect . Doctor Amir .
Speaker #9: hear me Can you now ?
Speaker #4: Yes , sir . can .
Speaker #10: Hear you .
Speaker #1: Sorry . Do you mind
Speaker #1: repeating that question ?
Speaker #8: I was Now we asking Yeah . So visibility the first question is how much into the blinded baseline patient characteristics data from the approach study and how this population may differ from a TRD population .
Speaker #8: And then on the safety database , what you'll need regulatory in a filing . Is minimum number of there a Retreatments per year needed in extend trial ?
Speaker #8: Thanks .
Speaker #9: Yes .
Speaker #1: Thank you. So, as safety is the trial is ongoing, the data is blinded. We are performing the necessary checks, or as many checks as are possible with blinded data, which essentially are quality checks in a blinded manner.
Speaker #1: And since this is a pivotal trial , we are of course being very careful with the data are . There checks other built into the database which there are that any ensures flags with respect data quality .
Speaker #1: There to are raised us to immediately if there is a reason for concern . So far we haven't any had flagged in the database .
Speaker #1: So we are confident that the data anything being maintained quality is in terms of how this is different from the TRD population . So group this is patients earlier treatment in the .
Speaker #1: these are So patients who are inadequately responding and they may failed have or they one treatment have failed one . been on But adequately not their second treatment . responding .
Speaker #1: these are So patients who are inadequately responding and they may failed have or they one treatment have failed one . been on But adequately not their second treatment .
Speaker #1: not fully And they not are that one third of the patient population that after multiple treatment trials . remains So But it's about two thirds of if you think depression of the population as a whole , this is the first two thirds of those patients in the cycle .
Speaker #1: Whereas TRD treatment would be two thirds left multiple treatment cycles . In terms of ends , the safety the safety database , the database really is a of function frequency of administration after the this is an .
Speaker #1: of intermittent have discussed with what we BTD discussions as that data that the we is provide to them , the provide to them will numbers that across the three studies , would be sufficient to support support an NDA .
Speaker #1: But of course , again , it what we find out in we long term the extension study with respect to treatment .
Speaker #1: frequency
Speaker #8: Thank you so much .
Speaker #8: Thank you so much .
Speaker #4: you Thank . Our next question will come Elmer from with Piros Capital Please go Partners . Lucid ahead .
Speaker #11: Yes . Thank . I you wanted to just get maybe just one tiny detail the on loan repayment . I if could clarify how was repaid you the the much prepayment penalty or the early repayment fees .
Speaker #12: Thank you we repaid high trail
Speaker #12: Yes , The the loan was as a structured And convertible they had converted the debt . other was
Speaker #11: They converted the other . Okay , okay .
Speaker #11: all . And thank you That's .
Speaker #12: very much welcome 30 million approximately . You're .
Speaker #4: Thank
Speaker #4: question with from Please go so .
Speaker #4: question with from Please go so Canaccord
Speaker #13: Good progress . morning . Nice And thanks for taking
Speaker #13: our questions . have
Speaker #13: program . How important 003 during your patients that is it remain compliant with their background antidepressant use I ? Sumant
Speaker #13: delivery ? the of the key challenges of developing an oral what are some formulation ? And my last question is .
Speaker #1: take the Eric can take the last one . Our So yes right , intramuscular is All the route of administration that we plan to progress in .
Speaker #1: Phase three . first two . It's very convenient form of administration , which also gives us what we need terms in of the plasma exposures and the acute which cannot experience , be achieved with something like oral , with oral , the .
Speaker #1: The elimination is pretty rapid and DMT or SIB for not reach does plasma . Peak levels . The threshold that is necessary for a breakthrough experience , which we , know is as we , is for necessary efficacy that we are achieving with intramuscular .
Speaker #1: It's tolerated . well So that is what we are going to take into phase three .
Speaker #6: And maybe I also add in there that the intramuscular route is one that, as we are aware from our market research with interventional psychiatry clinics, is being used currently and is also being administered by interventional psychiatrists with ketamine.
Speaker #6: And so that confidence gives us some that it is a route that will get that will adoption reach in the market . When launch .
Speaker #14: And with regard to your question regarding CEO qualities , I obviously , you know , we've been at it for mean , only about eight weeks right now .
Speaker #14: 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 .
Speaker #14: You know steward , successful capital that of investors feel can in , someone that confident has executed in the past , bringing a novel drug to market , ideally through commercialization .
Speaker #14: individual An that has , you know , transacted and dealt with big in the pharma past as well . These are all table stakes for us in the next individual that we'll be sitting in the chair .
Speaker #13: Thank
Speaker #13: you .
Speaker #4: you .
Speaker #4: this time , there are no further questions in the so I'd queue , Thank call back over to Eric for any closing like to turn the remarks .
Speaker #14: No further just want to thank remarks . I for everybody the call today attending . It's been very time exciting for Simon , and we look forward delivering some fantastic updates for , you know , everybody future .
Speaker #14: Thank you in the support your to .
Speaker #4: Thank you , ladies and gentlemen . This does conclude today's program and we appreciate your participation . You may disconnect