Helus Pharma Inc.

Helus Pharma Inc.

9.48
EUR
-0.33
(-3.41%)
-3.48EPS
Nov 16Next Earn

Q2 FY2026 · Earnings Call TranscriptNovember 13, 2025

Operator

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 Investors 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 sedarplus.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.

Eric So

Good morning, and thank you for joining us. This was 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 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 multi-visit standards, 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 will 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 3 studies for potential adjunctive treatment of major depressive disorder; and CYB004, our deuterated dimethyltryptamine, or DMT, program for the potential treatment of generalized anxiety disorder, is in Phase 2.

Clinically, our Phase 3 CYB003 program, which has been given breakthrough therapy designation in major depressive disorder, has continued to progress, including being granted additional clearances to commence EMBRACE, our second Phase 3 study, in new geographies. In generalized anxiety disorder, the Phase 2 CYB004 study completed enrollment and remains on track for a first calendar quarter 2026 topline 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 strengthened 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 in major depressive disorder, focusing on that study status, global footprint, and how the design supports real-world clinic operations and durable outcomes. Dr.

Inamdar will then review CYB004 in generalized anxiety disorder, including trial design, operational status following enrollment completion, and the timing and scope of the next data update.

Amir Inamdar

Thank you, Eric. Our Phase 3 PARADIGM program is moving forward as planned.

Dosing is underway in APPROACH across US 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, UK, 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 2 study of CYB004 and remain on track for topline data in the first calendar quarter of 2026. The study evaluates two intramuscular doses given three weeks apart, with efficacy assessed at six 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, 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.

Eric So

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 3 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, clinics can map out our protocols onto the schedules they already run.

Staggered starts, defined observation windows, and clear role 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 established 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 CYB003 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 managed 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 or 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 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 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 3 execution and manufacturing readiness, sites have reliable supply and predictable therapy days. For CYB004, resources move to database lock, protocol-specified analyses, and operational lift to topline.

Corporate use remains limited and targeted. The plan bridges us bridges us to the next two major event 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 now hand it off to Greg Cavers, our CFO, to walk through our second quarter financial results.

Greg Cavers

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 $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.

Eric So

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 clear geographies, keeping study conduct and data quality at the center of the plan as we progress towards a Phase 3 topline in Q4 of 2026. For CYB004, the path runs through database lock, protocol-specified analyses, and preparation of a clear topline package in the first quarter of 2026.

In parallel, we will advance commercial and manufacturing readiness, 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.

Operator

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.

We'll take our first question from Pete Stavropoulos with Cantor Fitzgerald. Please go ahead.

Sarah James

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 in GAD, you completed enrollment in early September, congratulations on that, and you have a readout in 1Q '26, 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? Then 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?

Amir Inamdar

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 sub-psychedelic, 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 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're looking for.

We'll share this in first quarter. We will aim to share HAM-A data out through 12...

Sarah James

Awesome, thanks. Then one more question from me.

The P2 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 for reimbursement?

Operator

Okay. One moment, please, while we reconnect Dr.

Amir.

Amir Inamdar

Can you hear me now? Sorry, I'm back.

Operator

Yes, sir. Now loud and clear.

Amir Inamdar

Apologies for that. Can you repeat the question?

Sarah James

The P2 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?

Amir Inamdar

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 would be thrilled to see effects that are maintained out to three months. We are hoping for better.

As with our Phase 2 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.

Sarah James

All right. Thank you so much.

Operator

Thank you. Our next question will come from Patrick Trujillo with H.C.

Wainwright. Please go ahead.

Patrick Trujillo

Thanks. Good morning, and congrats on all the progress.

I just wanted to get a clarification on the CYB-4 program just in terms of what we should expect as far as statistical powering and the definition of clinically meaningful HAM-A improvement. Then separately, I'm just wondering for CYB-3, what operational milestones remain to complete enrollment in APPROACH, and are site activations tracking to plan?

Amir Inamdar

Patrick, these two questions on CYB004. As I stated earlier, it's not a formally powered study.

We would however be looking at a improvement from baseline within-subject, within the arms. A clinically meaningful effect would be somewhere around 4 to 5 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 CYB-3 as well. CYB-3 is tracking as to plan, we remain on target to complete enrollment by mid of next year and deliver topline data by the end of next year.

Patrick Trujillo

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 CYB-3 and CYB-4, 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 CYB-3, we're looking at MDD, CYB-4 GAD, but 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.

Greg Cavers

Hi, thanks for that, Patrick. I'll take this one.

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 in the commercial metrics...

Operator

All right. One moment, it looks like he has disconnected.

If anybody else wants to take this question while we reconnect him.

Amir Inamdar

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 CYB-4. 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, and we believe with GAD for CYB-4 and with adjunctive in inadequate responders for CYB-3, those kind of address the spectrum of the most burdensome or most resource-intensive patients that you typically see in a psychiatry practice.

Operator

George has reconnected. I think Amir covered it well.

Thank you. All right.

Eric So

Thank you.

Operator

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

Laura Suriel

Hello, this is Laura Silva on for Jim Molloy. 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 US. Could you provide a bit more detail on the criteria behind choosing these sites and the activation process involved, and as well as when you might think you have all 45 of these sites fully activated and on board for the study?

Amir Inamdar

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, 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 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 would 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 topline data by the end of the year.

Sarah James

Great, thank you. Then also, I know the current focus right now is on the CYB003 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?

Amir Inamdar

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, and when there is information to share with the market, we will do so.

Sarah James

Understood. Thank you for taking the questions.

Operator

Thank you. Our next question will come from Eddie Hickman with Guggenheim.

Please go ahead.

Eddie Hickman

Good morning. Thank you for taking my question, and 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?

Secondly, what agreement do you have with the FDA relating to the safety database for 003, and what you'll need to provide in a regulatory filing? Is there a minimum number of retreatments per year needed in EXTEND?

Thank you. Yeah.

Amir Inamdar

Can you repeat the second question?

Operator

Dr. Amir, you're cutting in and out.

All right, please stand by while we reconnect Dr. Amir.

Amir Inamdar

Can you hear me now?

Operator

Yes, sir. Now we can.

Amir Inamdar

Yes, I can hear you. Sorry, do you mind repeating that question?

Eddie Hickman

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? Then on the safety database, what you'll need in a regulatory filing, is there a minimum number of retreatments per year needed in EXTEND trial?

Thanks.

Amir Inamdar

Yes. Thank you.

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 any flags with respect to data quality, they are raised to us immediately if there is a reason for concern.

Far, we haven't had anything flagged in the database, we're 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 1/3 of the patient population that remains after multiple treatment trials.

It's about 2/3 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 Ns, 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'll 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.

Eddie Hickman

Great. Thank you so much.

Operator

Thank you. Our next question will come from Elemer Piros with Lucid Capital Markets.

Please go ahead.

Elemer Piros

Yes, thank you. I just wanted to get maybe just one kind of detail on the loan repayment.

If you could clarify how much was repaid and what was the prepayment penalty or the early repayment fees?

Greg Cavers

Thank you. Yes, we repaid High Trail $20 million, and the repayment fee ended up being 10%.

Elemer Piros

10%. It wasn't a $50 million loan?

Just...

Greg Cavers

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

Elemer Piros

They converted the other. Okay.

Okay. That's all, and thank you so much.

Greg Cavers

You're very welcome.

Operator

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

Please go ahead.

Sumant Kulkarni

Good morning, and 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 antidepressants?

Operator

All right. One moment, please.

Amir Inamdar

Sorry, I was speaking on mute, Sumant. Taking that question, for our patients in the APPROACH study and in EMBRACE, because this is adjunctive, the instructions to the patients and requirements in the protocol is that they remain on their background antidepressant medications.

We do not expect them or advise them to come off their antidepressant medication during the treatment period.

Sumant Kulkarni

Got it. 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?

My last question is, what are some of the specific qualities that you believe are must-haves for an incoming CEO?

Amir Inamdar

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 elimination is pretty rapid, and DMT, or CYB-4, 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 3.

Eric So

Maybe I can just 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 when launched. With regard to your question regarding CEO qualities, 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 in the next individual that will be sitting in the chair.

Sumant Kulkarni

Got it. Thank you.

Operator

Thank you. At this time, there are no further questions in the queue, I'd like to turn the call back over to Eric for any additional or closing remarks.

Eric So

No further remarks. I just want to thank everybody for attending the call today.

It's been 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.

Operator

Thank you, ladies and gentlemen. This does conclude today's program, and we appreciate your participation.

You may disconnect at any time.