Definium Therapeutics Q3 2026 Earnings Call Transcript

Quartr
Provided by Quartr
November 9, 2026

Key Takeaways

  • Positive Sentiment: DT120 delivered positive Phase III results in GAD and MDD across three studies, with rapid, durable improvements and generally good tolerability. The results earned the program FDA breakthrough therapy designations in both indications.
  • Positive Sentiment: Definium remains on track to file an NDA for DT120 in the first half of 2027 and is preparing for a potential launch. However, the company did not disclose details of its FDA meeting or its filing strategy for MDD, where a second Phase III study, Ascend, is still underway.
  • Positive Sentiment: The company reported approximately $1.05 billion in cash, equivalents, and investments at quarter-end, which it expects to fund operations into 2030. R&D and G&A expenses increased year over year as Definium expanded development and commercial-readiness efforts.
  • Neutral Sentiment: Early DT402 results in autism spectrum disorder showed improvements across several social and functional measures, prompting the company to stop enrollment after five participants and plan a multi-day dosing study for 2027. The findings are preliminary, coming from a small, open-label study.
  • Neutral Sentiment: Definium is developing its supervised-treatment launch infrastructure and cited payer feedback indicating a potential pricing corridor of $30,000 to $75,000. Management said more payer discussions are needed to narrow that range and emphasized that provider readiness, access, and patient support will be important to adoption.
AI Generated. May Contain Errors.
Earnings Conference Call
Definium Therapeutics Q3 2026
00:00 / 00:00

There are 22 speakers on the call.

Operator

Good afternoon, and welcome to the Definium Therapeutics Third Quarter 2026 Financial Results and Business Updates webcast. Currently, all participants are in a listen-only mode. This webcast is live on the Investor and Media section of Definium' website at definiumtx.com, and a replay will be available after the webcast. I would like to introduce Gita Jain, Head of Investor Relations at Definium. Please go ahead.

Speaker 1

Good afternoon. I am Gita Jain, Head of Investor Relations, and thank you for joining us today for Definium Therapeutics Third Quarter 2026 Financial Results and Recent Business Highlights conference call. All participants are in listen-only mode. This webcast is available live in the Investor section of Definium' website, and a replay will be available following the webcast. Leading the call today will be Rob Barrow, our Chief Executive Officer, joined by Dr. Dan Karlin, our Chief Medical Officer, Brandi Roberts, our Chief Financial Officer, and Matt Wiley, our Chief Commercial Officer. During today's call, we will make forward-looking statements, including statements regarding the potential safety, efficacy, and clinical and regulatory progress of our product candidates, the timing and potential scope of regulatory submissions, our commercial preparations, our anticipated cash runway, and our future expectations, plans, and prospects.

Speaker 1

These statements are subject to risks and uncertainties, including those described in our filings with the SEC and applicable Canadian securities regulators, including our annual report on Form 10-K and our Form 10-Q filed today. Forward-looking statements are based on management's assumptions, opinions, and estimates as of today, November 9, 2026. You are cautioned not to place undue reliance on these statements. Definium disclaims any obligation to update them, except as required by law. With that, I will turn the call over to Rob. Rob?

Speaker 2

Thank you, Gita, and thank you, everyone, for joining us today. The third quarter marked an important inflection point for Definium. With positive phase III results across three studies and two large psychiatric indications, we have moved beyond demonstrating the promise of DT120 ODT to establishing a compelling body of evidence that supports its potential to fundamentally change how anxiety and depression are treated. We believe these results position DT120 to become an important new treatment option for millions of people who continue to face significant unmet needs, and reinforce our conviction that we have an opportunity to help shape the future of psychiatric care. Just as important, we are making meaningful progress toward realizing that opportunity. DT120 has now received two FDA breakthrough therapy designations, reflecting the potential of this program to address serious conditions with substantial unmet need.

Speaker 2

Our engagement with FDA remains constructive, and we are advancing with urgency toward our planned NDA filing in the first half of 2027. We are focused not simply on reaching the next regulatory milestone, but on doing the work necessary to be ready to deliver DT120 to patients and healthcare providers if approved. That preparation extends across the organization. We are building the commercial capabilities, deepening our engagement with the medical community, and developing the scientific and educational foundation that will be important to introducing a fundamentally different treatment approach. We recognize that realizing the full potential of DT120 will require more than strong clinical data. It will require a thoughtful approach to regulatory execution, access, provider education, and ultimately, the patient experience. Those priorities are shaping how we are building Definium for its next chapter. At the same time, we are continuing to advance the pipeline with potential beyond DT120.

Speaker 2

Today, we shared initial results from our DT402 study in adults with autism spectrum disorder, which demonstrated encouraging signals across measures of socialization, communication, and functional outcomes. These findings support our continued investment in DT402 and underscore our ambition to build this company with multiple products with the potential to make a meaningful difference across therapeutic areas. We enter the next phase of our journey with strong clinical validation, growing regulatory momentum, and an organization increasingly positioned to translate innovation into impact. There is still important work ahead, and we believe Definium is well-positioned to pursue the opportunity in front of us and ultimately bring new treatment options to the people who need them. With that, I will turn the call over to Dan to provide more details on our clinical progress.

Speaker 3

Thanks, Rob. We are pleased with the consistent DT120 clinical profile demonstrated in Emerge, Voyage, and Panorama. In each study, a single 100 microgram dose produced rapid and durable improvements in the disorders. Voyage enrolled 214 participants with moderate to severe GAD and met its primary endpoint and all key secondary efficacy endpoints. At week 12, DT120 showed a 5.4-point placebo-adjusted improvement on the Hamilton Anxiety Rating Scale, or HAM-A, with a P-value of less than 0.0001 and a Cohen's d effect size of 0.81. Improvement was evident as soon as day one at the first HAM-A assessment at week one and was maintained through week 12. Panorama demonstrated similar results in 245 participants. The 100 microgram dose led to a 5.1-point placebo-adjusted improvement on the HAM-A at week 12, with a P-value of less than 0.0001 and a Cohen's d of 0.64.

Speaker 3

The study met its primary endpoint and all key secondary efficacy endpoints. The 50 microgram functional control further supported the interpretability of the efficacy and supported our selection of the 100 microgram dose. Our positive Emerge results announced in June provide strong support for the DT120 program in MDD. Emerge met its primary endpoint and all key secondary endpoints, demonstrating a rapid, clinically meaningful, and durable treatment effect following a single dose, with efficacy evident as early as day one and sustained through week 12. Based on these results, FDA granted breakthrough therapy designation to DT120 ODT for MDD, in addition to the previously granted breakthrough therapy designation for GAD. In the completed double-blind phases of all three studies, DT120 was generally well tolerated, with no drug-related serious adverse events and no suicidality signal. Most treatment-emergent adverse events occurred and resolved during the observed dosing session.

Speaker 3

Treatment session dynamics were predictable and manageable. Participants completed the standardized end-of-session checklist in an average of about six hours consistently across the studies. Our fourth phase III study, and second in MDD, Ascend, continues to enroll well, with top-line data expected in 2027. We look forward to initiating Haven, our phase III study in post-traumatic stress disorder, or PTSD, in 2027. PTSD remains an area of significant unmet need, and we believe there is a compelling rationale to evaluate DT120 in PTSD based on the clinical profile we've observed in GAD and MDD. We plan to enroll approximately 200 participants, with change in a clinician-administered PTSD scale for DSM-5, or CAPS-5, at week eight as the primary endpoint.

Speaker 3

As our DT120 clinical program advances, we are expanding our already substantial medical affairs team, including our field-based medical science liaisons, who engage with healthcare professionals to learn about and educate on the burden of disease, the emerging treatment landscape, and the growing body of evidence supporting DT120. Their work extends our clinical efforts as we prepare for regulatory submission, and ultimately helps ensure the medical community has a strong understanding of the data and DT120's potential role in treating anxiety and depression. Turning to DT402 for ASD. Our phase IIa study was a single-dose, open-label design to characterize DT402's pharmacodynamic and clinical effects, and to explore changes in measures of social behaviors and experiences, communication, and other functional outcomes. We were able to detect a sufficient signal to stop the study after enrolling five participants.

Speaker 3

During treatment, several measures improved, including reduced rigidity and fixation, increased engagement in social settings, increased empathy and closeness to others, and reduced anxiety and irritability. DT402 was well tolerated, with the most common adverse events being euphoria, fatigue, and enhanced relaxation. This was a small, early-stage study, and the findings should be viewed in that context. Nonetheless, the consistent improvements across multiple measures are encouraging and support continued development. We plan to initiate a study in 2027 that will investigate the safety and clinical activity of multi-day dosing paradigms. ASD remains another area of substantial unmet need, particularly for therapies that can address core social perception and communication challenges. DT402 gives us an ongoing opportunity to develop our pipeline while remaining closely aligned with our scientific expertise and mission.

Speaker 3

Taken together, the breadth and consistency of the DT120 data and the positive initial DT402 findings position Definium with both a potential near-term commercial product and a promising second asset. I'll now turn the call over to Matt. Matt?

Speaker 4

Thanks, Dan. The strength and consistency of the DT120 data allows us to plan for launch with increasing clarity and sustained urgency. We continue to advance the commercial infrastructure and capabilities needed to support DT120 if approved. Our focus is on translating that strong clinical profile into a launch model that works for patients, providers, and payers. We have advanced our market access strategy, distribution planning, patient services, commercial operations, and field deployment plans, while continuing to build the infrastructure needed to support the supervised treatment model. Provider and site readiness are critical to a successful launch. We are engaging the established and growing ecosystem of interventional psychiatry providers to assess capacity, workflow, and infrastructure needs, and to identify opportunities for additional support well ahead of launch. These insights are directly informing how we design our field organization, develop patient services, and equip providers to deliver DT120.

Speaker 4

Patients are central to our commercial planning. We recently expanded our outreach efforts by bringing on a head of patient advocacy, who will help advance our important work with patients and advocacy organizations and incorporate their perspectives to inform our approach. This will complement our ongoing efforts in marketing and patient services to help us refine our understanding of the patient journey, identify barriers to care, and build education and support resources that can help patients access treatment. Our goal is not simply to make DT120 available. It's to create the conditions for rapid, responsible adoption and a strong patient and provider experience. We are planning our first Commercial Day in the first half of 2027. At that event, we will share a more detailed view of the market opportunity for DT120, our go-to-market approach, and our launch preparations.

Speaker 4

The important takeaway is that we're moving beyond commercial planning and putting our strategy, infrastructure, and capabilities in place for potential launch. I'll now turn the call over to Brandi for our financial results.

Speaker 5

Thank you, Matt. As of September 30, 2026, cash equivalents, and investments were approximately $1.05 billion, compared with $411.6 million as of December 31, 2025. Based on our current operating plan and anticipated milestones, we expect these resources to fund planned operations into 2030. Research and development expenses were $46.1 million for the third quarter of 2026, compared with $31 million for the same period in 2025. The increase primarily reflected higher personnel-related costs associated with the expansion of our R&D organization and increased spending on the DT120 development program. General and administrative expenses were $26.1 million for the third quarter of 2026, compared with $14.7 million for the same period in 2025. The increase primarily reflected investments in corporate and government affairs, commercial preparedness, and personnel as we expanded our organizational capabilities, as well as higher legal and patent expenses.

Speaker 5

Overall, our operating expenses for the quarter were consistent with our expectations. As anticipated, spending moderated somewhat compared with the second quarter as we moved through several key clinical readouts while we continued to invest in the capabilities and the infrastructure needed to prepare for potential commercialization. Net loss for the third quarter of 2026 was $51 million, compared with a net loss of $67.3 million for the same period in 2025. The decrease in net loss was primarily attributable to a gain from the change in fair value of our 2022 financing warrants and higher interest income, partially offset by increased operating expenses. Few companies at our stage have the financial strength that we have today. It gives us the ability to invest decisively behind DT120 and the opportunity we see ahead of us without having to compromise the scale or quality of our launch preparation.

Speaker 5

We intend to use that advantage. With potential indications in GAD and MDD, two of the largest areas in psychiatry, and no new treatment approved for GAD in 20 years, we believe the opportunity for DT120 is substantial. That makes investing appropriately today incredibly important. We believe the right investments now can generate significant returns over the long term, and we remain highly focused on maximizing the potential of DT120 and creating value for patients, providers, and shareholders. With that, I'll turn the call back over to Rob.

Speaker 2

Thanks, Brandy. The progress we reported today reflects years of scientific rigor and disciplined execution. We have three positive phase III studies for DT120 in GAD and MDD, breakthrough therapy designations in both indications, and we remain on track for NDA filing in the first half of 2027. We have great confidence in the clinical evidence and commercial strategy for DT120 ODT and remain focused on our vision to enable exceptional outcomes and care for the millions of patients living with GAD, MDD, PTSD, and other mental health disorders. We're closing out 2026 with exceptional momentum and over $1 billion to invest in delivering on this vision. I want to thank the patients, investigators, employees, and partners whose commitment has made this progress possible and look forward to sharing further updates as we progress in 2027 and beyond. With that, we're happy to take your questions.

Operator

Thank you. Ladies and gentlemen, if you have a question or comment at this time, please press star 11 on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue, simply press star 11 again. Again, if you have a question or comment at this time, please press star 11 on your telephone keypad. To allow us to get as many analysts as possible, please limit yourself to one question and rejoin the queue for any follow-up questions. Please stand by while we compile the Q&A roster. Our first question or comment comes from the line of Tessa Romero from JPMorgan. Your line is now open.

Speaker 6

Hi, Rob and team. Thanks so much for taking our questions this evening. Just one from us. Are you able to opine on if the pre-NDA meeting has taken place for DT120 ODT, or if not, when it will? How do you plan to share the outcome of this meeting, and will this come after your meeting minutes are received? Thank you.

Speaker 2

Hey, thanks so much for the question, Tess. We are really excited about our engagement with FDA and all of our ongoing dialogue. We obviously have a very regular dialogue with the agency over the past several years, and certainly over the past several months as we have had phase III data. As you suggested, once we have meeting minutes in hand is typically when we are in a position to share details from meetings. We do not want to get ahead of ourselves in anything, but again, that constructive dialogue we have had on an ongoing basis has us really excited about the path forward, and we are moving ahead very quickly here to prepare for an NDA filing in the first half of next year.

Operator

Thank you. Our next question or comment comes from the line of Andrew Tsai from Jefferies. Your line is now open.

Speaker 7

Hey, guys. This is John on for Andrew. Thanks so much for all the updates. With COMP360 to be approved and launched in the first half of 2027, maybe just talk through some of the things you will be monitoring closely for the launch to potentially help inform your own launch for DT120, which could happen, I guess, in about a year from now potentially. Is there anything you will be looking to glean specifically that is unique to COMP360 and perhaps even different from SPRAVATO? Thanks.

Speaker 2

Yeah. Thanks so much for the question, John. I think at the highest level, we're of course seeing momentum for the entire field and knowing that having multiple potential opportunities for drugs to be out in the market really gives, we think, providers the ability to lean in and find themselves in a position to broaden out the footprint where this product can potentially be delivered. So, obviously, there's so many patients in such great need, and we feel really confident about the profile of DT120. We're going to be following everything closely and obviously have our own thoughts, plans, strategy around how to get this out in the most impactful way. So, yeah, certainly going to be watching and trying to position ourselves to be in a position to launch as effectively and broadly as possible, if we get the drug approved.

Operator

Thank you. Our next question or comment comes from the line of Tazeen Ahmad from Bank of America. Your line is now open.

Speaker 8

Hi. Thank you for taking my question. One quick one. If the Ascend study reads out during your review period for your initial NDA, do you think that you would be able to If there's any question about needing a second study for MDD, do you think you would be able to amend the original filing, or do you think you would, if the FDA wants to keep them separate, just keep them separate without trying to initiate any additional discussions, assuming that Ascend is positive when it reads out? Thanks.

Speaker 2

Got it. Thanks so much for the question. It is one that, in terms of filing strategy, once we're in a position to share further specifics, we certainly are looking forward to that. There are a lot of avenues that are potentially available to sponsors filing. As we think about both of these very important, very large indications, we're focused on driving the most efficient path to market and having the highest quality evidence we're able to put behind it. So, we're really encouraged by the momentum with the Ascend study. It's only picked up since we had MDD data from Emerge earlier in the year. In terms of the sequencing and the ability and the data that would be submitted at various points in a review cycle, I think we'll reserve any specifics there until we're able to talk holistically about the overall filing strategy.

Speaker 2

But needless to say, we're really excited about the path forward and the ability to have an efficient process for both these indications.

Operator

Thank you. Our next question or comment comes from the line of Paul Matteis from Stifel. Your line is now open.

Speaker 9

Hi there. This is Matthew on for Paul. Thank you so much for taking our question, and congrats on all the progress. I guess from us, with the recent Usona filing for depression, does that at all change your commercialization or pricing strategy as you're thinking about the MDD market? Thank you so much.

Speaker 2

Yeah. Thanks so much for the question. Fundamentally, no. I'm happy to ask Matt Wiley to elaborate further, but we, of course, all of us feel very close, and we feel very comfortable with the positioning of our product and its ability to meaningfully differentiate from the psilocybin products and being in a great position. But Matt, I don't know if you want to add any specifics there.

Speaker 4

I would just go back to previous statements that I've made about the pricing corridor that payers have advised us that they see the pricing corridor here somewhere between $30,000 to $75,000 that they currently pay for SPRAVATO. As Rob said, there's differentiated value here. As we have payer discussions in the future, we'll be able to narrow that corridor, but we feel pretty good about the feedback we've gotten so far.

Speaker 9

Thank you.

Operator

Thank you. Our next question or comment comes from the line of Marc Goodman from Leerink. Your line is now open, sir.

Speaker 10

Dan, what are the challenges of running and being successful with a PTSD study in this type of asset, just relative to what we kind of all are a little more well-versed on with MDD and GAD? Thanks. If there are any.

Speaker 2

Yeah. Dan, do you want to go ahead and take that one?

Speaker 3

Yeah, sure. Thanks for the question, Marc Goodman. We're really excited about PTSD, and while each indication has its own unique patient access challenges and things like this, we don't fundamentally think that this is going to be in any way more difficult than what we've done already. We have a lot of confidence in the asset and a lot of confidence in our clinical development team that's gotten us as far as they have, and our clin ops folks as well. We're excited to get started and be able to gather some evidence in this novel and really important population.

Operator

Thank you. Our next question or comment comes from the line of Gavin Clark-Gartner from Evercore ISI. Your line is now open.

Speaker 11

Sorry, can you hear me?

Operator

We can hear you now, ma'am. Go ahead.

Speaker 11

Oh, perfect. This is Yashalyn for Gavin. We were just wondering, on DT402, could you maybe expand on why you stopped enrollment after five patients and what you saw that kind of gave you confidence to move into the multiple dose study? Was that decision based on pre-specified stopping rules or kind of review of the emerging data? Thank you.

Speaker 2

Thanks so much. I'll turn it over to Dan to elaborate initially. Happy to add anything, Dan.

Speaker 3

For sure. Yes, so with DT402 and the study we've just wrapped up, the goal from the outset there was to look for what we would call early signals of efficacy. This was a single-dose open-label study looking at drug response parameters over the course of that single dosing day. What we had decided from the outset was that if we saw a strong and consistent signal, that we would stop when we didn't think there was more to be learned from the study. At the point where we were, we saw a consistent enough signal, and the signal was in the right direction, had a real solid magnitude, and there was no reason to keep enrolling participants in the study. We have a lot of confidence moving forward from here.

Operator

Thank you. Our next question or comment comes from the line of David Amsellem from Piper Sandler. Your line is open.

Speaker 12

Hey, thanks. Another question on DT402, and I know this is early days in the development program, but maybe talk to validated scales in terms of measuring the things that you're looking for, like social engagement, and what you're going to be incorporating in terms of outcome measures in the multi-dose trial. Also, what did you see early on from the handful of patients in terms of the monitoring period, and how long do you expect those patients are going to have to be monitored relative to what's been incorporated and what you're seeing for DT120? Thanks.

Speaker 3

Yeah, it's an excellent question, and one that has some open questions built into it. The historical Vineland scale that's been used for ASD does have an explicit social communication subscale. Using older established scales is going to be very much on the plan, but we're also excited to be able to show the sort of day-to-day change that we expect to be able to generate with the molecule based on what we've seen so far. We'll use a combination of established scales with at least some precedent of being put in front of regulators, though obviously with no drugs approved for the core symptoms of ASD.

Speaker 3

There's some white space there, and we, as folks who are quite interested in measurement and the best ways to get at the answers to the kinds of questions we'd like to ask of the drug, will engage in a collaborative process with all stakeholders in the autism community and the regulatory community to be sure that we're not leaving any opportunity to measure potential improvement on the table.

Operator

Thank you. Our next question or comment comes from the line of Brian Abrahams from RBC Capital Markets. Your line is now open.

Speaker 13

Hi, everyone. This is Navin on for Brian. I just wanted to go back and ask a follow-up on some of the recent updates from Usona. Just given the potential NDA filing that they've had, given that they have a commissioner's priority review voucher, we'll likely hear about that in the next couple of months. Just given the closeness with your own pre-NDA meeting, as well as how you're kind of thinking about positioning MDD as well, is there maybe a chance to wait to see how Usona's filing might play out to see if whether you might also be able to file on a single and large phase III pivotal trial as well? Just wondering your kind of thoughts on that overall.

Speaker 2

Yeah. Thanks so much, Navin. I mean, I think our focus has been on executing our program and executing on what we believe is the right path for this drug and for these indications. We're obviously always looking at things that are happening with other programs and the regulatory framework and all of that. We've tried to develop our program and our package to provide the strongest possible evidence base while not sacrificing timing or efficiency to get a product to market where there's a really urgent need out there. As we think across both GAD and MDD, the profile of the drug and the path forward and the timing of data and submissions and such, again, we can provide a little bit more specifics on those fronts as we get to that point.

Speaker 2

But we'll watch and we'll see, but it's not going to really change the course. We believe we have the right path ahead, the right strategy, and we're going to keep executing on that as we have since the inception of this program.

Operator

Thank you. Our next question or comment comes from the line of Francois Brisebois from LifeSci Capital. Your line is now open.

Speaker 14

All right, thanks for the question. I was just wondering if you could, just a little further on Marc's previous question on PTSD, if you could just help us understand a little bit more the CAPS-5 and why week eight is the right week to test drugs in this space.

Speaker 2

Yeah, thanks, Frank. I'll turn it over to Dan to cover that one as well.

Speaker 3

Yeah, the CAPS is a clinician-assessed, regulatorily acceptable measure of PTSD that's been used by pretty much everyone in the field, based on the newest definition of PTSD from DSM-5. Week eight has real regulatory precedent as well, so that is why we're going with week eight. We'll still have our full 12-week double-blind period, just as we have in our other studies, so we'll have data from out to week 12 in a double-blind fashion. Given our ability to move- All of the scales that we've used as our primaries to move from MADRS and the HAM-A, we remain extremely confident that any scale that's a reliable clinician-assessed scale of the disease state where we are likely to have efficacy won't be a problem for us. So, a lot of confidence heading into this PTSD study.

Speaker 14

Thank you.

Operator

Thank you. Our next question or comment comes from the line of Matthew Hershenhorn from Oppenheimer. Your line is now open.

Speaker 15

Oh, hey, guys. Congrats on the amazing year, and thanks for taking our question. As you anticipate initiating phase III Haven for PTSD, could you talk about any of the recent commentary and outlook from the VA in terms of highlighting the unmet need there for veterans and making psychedelics more available, and particularly how DT120 could address these patients? Also, would you expect a meaningful proportion of the Haven study to include veterans? Appreciate any color there. Thank you so much.

Speaker 2

Yeah. Thanks so much, Matt. I think one of the really important aspects here is to not forget that while PTSD is certainly a prominent and very focused-on diagnosis, there are many veterans suffering from anxiety and depression as well. We are already very much focused on that population and the ability to broaden out access and be able to deliver this to as many patients as could potentially benefit from it. As we think about PTSD in particular, and as we think about, also, I think even more importantly, getting DT120 potentially out into the world, we're very much engaged with the VA, with a number of stakeholders, and connected to that care setting as well, and will remain so. We want to be at the forefront of every one of these opportunities with every one of these communities.

Speaker 2

And part of the opportunity as well is broadening out indications to have the opportunity, if we are successful in all three programs, to have both anxiety, depression, and PTSD eventually on the label. That just gives us a really, we think, an appropriately broad entry point to try to benefit as many patients as we can. Dan, I do not know if you want to elaborate at all on some of the early work with VA.

Speaker 3

Yeah. I mean, like Rob said, we really value the relationship we have had with the VA as a site in MDD and GAD, and of course, in PTSD, that is a patient population that exists at the VA as well. So, we absolutely anticipate that we will work with VA sites on the study, and of course, have non-VA sites too. We want to make sure that we are representing a real generalizable and broad population with PTSD, because PTSD can look like some different things depending on the origin of the trauma. So, yes, at the VA, yes, also outside of the VA, and that is a relationship we will continue to foster as we move along.

Speaker 15

Got it. Makes perfect sense. Very helpful. Thank you so much.

Operator

Thank you. Our next question or comment comes from the line of Sumant Kulkarni from Canaccord Genuity. Your line is now open.

Speaker 16

Good afternoon. Thanks for taking our question. Assuming DT120 is approved for both MDD and GAD, what is your latest market research telling you on which indication you might expect to see a quicker ramp, and what the specific reasons might be for any sources of differential uptake?

Speaker 2

Yeah. Thanks so much, Sumant. I think initial pass, and certainly I can ask Matt to elaborate, I would say that fundamentally, when we look at the high degree of overlap in these populations, there are certainly different dynamics at play. Generalized anxiety disorder is an area where we have not had a new product in almost 20 years, right? The opportunity to really represent something brand new in terms of any sort of treatment option, but also certainly in terms of the uniqueness of what we are doing, is really exciting there. Obviously, some of that is also represented in some patterns of focusing on the diagnosis of MDD over the past several years. Both have unique characteristics that can shape that uptake curve. We feel very excited about both of those independently, and especially together.

Speaker 2

The opportunity to potentially have something that could help with both anxiety and depression is really encouraging, really exciting for us. Matt, if you want to elaborate on that at all.

Speaker 4

Yeah, I will just make one additional point, is that in previous market research that we have done with both GAD and MDD patients, and this was something that we did present at the Investor Day earlier this year, is that those that have been failed by multiple therapeutics, regardless of indication, those patients have a higher likelihood to try DT120. So, those patients who have been failed by five or more medications, 65% of them indicated that they would like to try DT120. So, to Rob's point, we do not really see a differentiation by indication. We actually see that patients in need are highly likely to ask their physician about this.

Operator

Thank you. Our next question or comment comes from the line of Pete Stavropoulos from Cantor. Your line is now open.

Speaker 17

Hi, Rob and team. Congratulations on the quarter. With regards to the study design for PTSD, mainly patient selection, PTSD is heterogeneous in terms of trauma exposure, chronicity, psychiatric comorbidities. Are there any particular patient characteristics that you believe could lead patients to have a stronger response to DT120, and how might those inform the enrollment criteria? Would you focus on this as a monotherapy, or will you move forward with patients on standard of care?

Speaker 2

Yeah, thanks so much, Pete. I'll turn that one over to Dan as well.

Speaker 3

Yeah, thanks for the question. One of the strengths of DT120 in particular is that, again, as we've shown now in GAD and MDD, we seem to be able to demonstrate efficacy across a range of heterogeneous populations. As compared to something with, say, a much narrower mechanism, the ability to be a little more agnostic as to the finer grain nature of the patient presentation. Of course, we'll limit comorbidities as we have in prior studies to people with histories of mania or psychosis. Beyond that, once we get into the moderate to severe category of PTSD, we're going to take a pretty broad swath of that population. So, normal drug development limitations on medical comorbidities and psychiatric comorbidities, and we fully expect to run these studies as a monotherapy as we have in other indications.

Speaker 3

But that's more for interpretability and cleanliness of the data than it is for the ultimate intention for how the drug will be used. The most successful psychiatric drugs are established as monotherapies. They ultimately become used as a part of polypharmacy, sometimes to a fault. We intend to continue to demonstrate our primary evidence as monotherapy while demonstrating that the drug can be used safely as a component of a multi-drug strategy.

Speaker 17

Awesome. Thank you for answering the question.

Operator

Thank you. Our next question or comment comes from the line of Chris Chen from Baird. Your line is now open.

Speaker 18

Hi, everyone. Thanks for taking my question, and congrats on the successful quarter. Just wanted to turn it back to DT120. As you've had more time to dig into the data across the three trials there, can you share any updates on how patient profile may be impacting response and remission rates? Are you able to point to any key drivers that may be separating those responders from non-responders and remitters from non-remitters? Thank you.

Speaker 2

Yeah, thanks so much for the question, Chris. That is really an exciting one. As more unfolds and as we put more out and are able to publish on some of these findings, we are really excited to share some of the insights there. I think the dynamics of what we are seeing, of course, I think we are always interested in trying to understand baseline characteristics that could predict response. But one of the really interesting findings is really related to response patterns and treatment dynamics and what we can learn over the course of treatment. We continue to accrue data from part B of the studies and continue to further elucidate the response patterns and those patient pathways across the course of an entire year.

Speaker 2

As we are able to share more specifically, I think there are some really interesting and potentially quite valuable insights that we will be able to share. A little bit early for me to answer fully, but again, great question, and something we are very much eager to get out there in the world here in the not-too-distant future.

Operator

Thank you.

Speaker 18

Great. Thank you.

Operator

Thank you. Our next question or comment comes from the line of Patrick Trucchio from H.C. Wainwright. Your line is now open.

Speaker 19

Thanks. Good afternoon, and congrats on all the progress. Clearly, the benefits in MDD and GAD and potentially PTSD are very clear. I am wondering if you can talk about, as we look further out in the longer term, where you could see DT120 expanding beyond here, clearly understanding we have quite a large patient population with the existing indications. I am wondering, based on the data you have seen, where you think maybe there is potential longer term.

Speaker 2

Yeah, it is a great question. Thanks, Patrick. We are certainly premature to talk specifically about which indications we will be or would be pursuing in the future. We do think quite expansively, not only about broadening patient populations potentially, but about giving confidence in terms of entry points for care so that regardless of presentation or the nature of symptoms, we can broaden out in those other populations, especially those that are somewhat distinct, either diagnostically or symptomatically from what we are treating today. Certainly thinking also in the future about where we can go to broaden out the population and be clear about who all inside of GAD and MDD and PTSD could benefit and how they could benefit. So, something that we are very actively engaged in and thinking about for the future.

Speaker 2

As we get to refinement of those plans and a clear path for potential expansion and other indications, we will certainly be eager to share more there as well.

Operator

Thank you. Our next question or comment comes from the line of Ami Fadia from Needham & Company. Your line is now open.

Speaker 20

Hi, this is Poorna on for Ami. Thank you for taking our question. Currently, what is the magnitude of GAD patients that get treated in clinics relative to TRD or MDD? What do you believe will be needed to drive patient and physician awareness and drive patient flow to these clinics? Do you also believe that the uptake for MDD may be faster than GAD? Thank you.

Speaker 2

Yeah, thanks so much for the question. When we think about these indications, we really don't think about them as entirely independent from one another, and it would be sort of odd to do so given the high degree of overlap. Some of the more recent years of prescribing has also been influenced by the reality that new treatment options have almost been, for the last 20 years almost, have been exclusively for MDD and not for GAD. There's quite an interplay there between the lack of available treatments and the prescribing and treatment patterns. When we think about the opportunity, we think about it pretty holistically and encompassing both those GAD and MDD patients together. Matt, I don't know if you want to add any further specifics in terms of how we think about it.

Speaker 4

No, the only other point I would add is on referrals and referral networks for the clinics. There are some that are established now, but it's incumbent on us to build the story in the psychiatrist's offices so they're aware of DT120, if approved, and that we have an indication in GAD, and being able to identify those patients in their practice that might be appropriate where they may want to refer out to one of these clinics. There are GAD patients in the clinics today being treated. We know that from data. Better than half of these SPRAVATO patients, by our calculations, also have comorbid GAD, so they are being treated. There's a lot of good work ongoing to map out those referral networks and to ensure that they have the right information at launch if we're approved.

Operator

Thank you.

Speaker 20

Okay. Thank you.

Operator

Our next question or comment comes from the line of Rudy Li from Wolfe Research. Your line is now open.

Speaker 21

Hey, thanks for taking my question. Can you provide additional color on the end of session checklist for DT120? Maybe just talk about the corner cases for patients who need to stay longer than eight hours. Usually, what would be the key limiting step or items, and how to handle those cases in practice? Thank you.

Speaker 2

Yeah, thanks so much, Rudy. We feel really comfortable both in terms of the data we're seeing in the studies, in terms of our engagement with clinicians, and the viability of the DT120 profile in those settings. While there certainly are some very uncommon cases where we see patients who need a little bit more time to clear, we actually see some encouraging dynamics that we've yet to be able to share fully in terms of those data over time. We also, again, in all of our engagement with sites who are providing care today, have yet to see any real concern. There's some anecdotes from some of the studies where, for instance, some of the edge cases, and one in particular, a patient fell asleep and the site decided not to wake them up for a couple hours.

Speaker 2

As such, we had to report it out as being longer than eight-hour monitoring. That, of course, in the real world, if someone is asleep and the site wants to keep them there and let them sleep it out, then that's perfectly fine. They have the discretion to make that decision, but we're not seeing anything that, in our minds, is concerning or would be anything but really viable and adaptable to a real-world setting in the data so far.

Speaker 21

Thanks for the color. Very helpful.

Speaker 2

Thanks, Rudy.

Operator

Thank you. I'm showing no additional questions in the queue at this time. I would like to turn the conference back over to management for any closing remarks.

Speaker 2

Thank you all for joining us again today. It's been an incredibly exciting year and incredibly exciting quarter. As we head into the end of the year and get ready to kick off 2027, we have never been more excited about the potential of our organization or DT120, or the opportunity to really have a profound impact on the field of psychiatry. Thank you again for being here and for all the support along the way, and we look forward to being together again soon.

Operator

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day.

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