Definium (DFTX) Q3 2026 Earnings Call Transcript

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DATE

Monday, Nov. 9, 2026

CALL PARTICIPANTS

• Head of Investor Relations - Gitanjali Jain
• Chief Executive Officer - Robert Barrow
• Chief Medical Officer - Daniel Rollings Karlin
• Chief Financial Officer - Brandi L. Roberts
• Chief Commercial Officer - Matthew Wiley

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TAKEAWAYS

• Cash and Short-Term Investments -- $1.05 billion as of Sept. 30, 2026, compared with $412 million as of Dec. 31, 2025, following successful financing activities.
• Anticipated Cash Runway -- Funding for planned operations is expected to extend into 2030 based on the company's current capital position and milestone projections.
• Research and Development Expenses -- $46.1 million for the third quarter, an increase from $31 million primarily driven by personnel expansion and DT120 development costs.
• General and Administrative Expenses -- $26.1 million for the third quarter, compared with $14.7 million reflecting investments in corporate affairs and commercial preparedness.
• Net Loss -- $51 million, a decrease from $67.3 million due to higher interest income and gains from the fair value change of USD financing warrants.
• Phase 3 Voyage GAD Results -- 5.4 point placebo-adjusted improvement on the HAM-A scale at week 12 (p<0.0001, Cohen's d=0.81) using a single 100 microgram dose.
• Phase 3 Panorama GAD Results -- 5.1 point placebo-adjusted improvement on the HAM-A scale at week 12 (p<0.0001, Cohen's d=0.64) in 245 randomized participants.
• Phase 3 Emerge MDD Results -- Positive clinical data led to a second FDA breakthrough therapy designation for DT120 ODT, specifically for the treatment of major depressive disorder.
• Phase 3 Ascend MDD Trial -- Enrollment target of approximately 165 participants is currently active, with management anticipating top-line results in 2027.
• Phase 3 Haven PTSD Trial -- Management plans to initiate this study in 2027 with approximately 200 participants and a week 8 primary endpoint using the CAPS-5 scale.
• Phase 2a DT402 Signal -- Enrollment was terminated after five participants due to a sufficient signal in social engagement and communication, informing the next phase of development.
• Planned NDA Submission -- The company remains on track to file its New Drug Application for DT120 ODT in the first half of 2027.
• Commercial Pricing Corridor -- $30,000 to $75,000 per treatment course based on preliminary feedback from health care payers regarding the interventional psychiatry market.
• Clinical Monitoring Duration -- 6 hours on average for participants to complete the standardized end-of-session checklist across all Phase 3 clinical studies.
• Commercial Day Schedule -- Management scheduled its first Commercial Day for the first half of 2027 to detail its go-to-market strategy and market opportunity.

SUMMARY

Definium Therapeutics, Inc. (NASDAQ:DFTX) reported a strategic transition toward regulatory submission and precommercial activities following positive Phase 3 results for DT120 ODT in generalized anxiety disorder and major depressive disorder. Management stated that the company remains on track to file its New Drug Application in the first half of 2027 and is actively expanding its medical affairs and commercial infrastructure. The company reported a cash balance of $1.05 billion, which management indicated provides a capital runway extending into 2030. Management indicated that the current strategy focuses on optimizing site readiness and provider education to support a potential launch in two of the largest indications in psychiatry.

• Chief Commercial Officer Wiley stated that payer feedback established a pricing corridor of $30,000 to $75,000 for the DT120 ODT treatment course, consistent with existing interventional psychiatry benchmarks.
• Chief Medical Officer Karlin noted that the Phase 2a study for DT402 in autism spectrum disorder was stopped after five participants because the signal magnitude was sufficient to inform upcoming multiday dosing trials.
• Management reported active engagement with the Department of Veterans Affairs as both a clinical site and a potential future care setting for patients with anxiety, depression, and PTSD.
• Wiley indicated that more than 50% of current interventional psychiatry patients for related products have comorbid generalized anxiety disorder, suggesting established referral pathways for DT120 ODT.
• CFO Roberts stated, "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."
• CEO Barrow stated, "We have 3 positive Phase 3 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 27."

INDUSTRY GLOSSARY

• DT120 ODT: A proprietary orally disintegrating tablet formulation of lysergide (LSD) being developed for psychiatric disorders.
• DT402: An R-enantiomer form of 3,4-methylenedioxymethamphetamine (MDMA) targeting autism spectrum disorder core symptoms.
• HAM-A: The Hamilton Anxiety Rating Scale, a clinician-administered assessment tool used to measure the severity of anxiety symptoms.
• CAPS-5: The Clinician-Administered PTSD Scale for DSM-5, a standardized assessment for diagnosing and monitoring post-traumatic stress disorder.
• Zydis ODT: A fast-dissolve technology used to improve drug absorption and bioavailability while reducing gastrointestinal side effects.
• Breakthrough Therapy Designation: An FDA process designed to expedite the development and review of drugs for serious conditions that show preliminary clinical evidence of substantial improvement over existing therapies.
• Cohen's d: A statistical measure of effect size used to indicate the standardized difference between two means in clinical research.

Full Conference Call Transcript

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's website at definiumtx.com. And a replay will be available after the webcast. I would like to introduce Gitanjali Jain, head of investor relations at Definium. Please go ahead.

Gitanjali Jain: Good afternoon. I am Gitanjali 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 Investors section of Definium's website and a replay will be available following the webcast. Leading the call today will be Robert Barrow, our chief executive officer joined by Dr. Daniel Rollings Karlin, our chief medical officer, Brandi L. Roberts, our chief financial officer, and Matthew 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. 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 as of today, 11/09/2026. 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 Robert. Robert?

Robert Barrow: Thank you, Geeta, and thank you, everyone, for joining us today. The third quarter marked an important inflection point for Infinium. With positive Phase III results across 3 studies and 2 large psychiatric indications, we have moved beyond demonstrating the promise of DT120 ODT, established a compelling body of evidence that supports its potential to fundamentally change how anxiety and depression are treated. We believe these results position GT-120 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 2 FDA breakthrough therapy designations. Reflecting the potential of this program to address serious conditions with substantial unmet need. Our engagement with FDA remains constructive, and we are advancing with urgency toward our planned NDA filing in the first half of 27. We are focused not simply on reaching the next regulatory milestone, but on doing the work necessary to be ready to deliver DT21 to patients and health care 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 DT21. 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 Daniel to provide more details on our clinical progress.

Daniel Rollings Karlin: Thanks, Robert. 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, DT21 showed a 5.4 placebo adjusted improvement on the Hamilton anxiety scale or HAM-A with a p value of less than 0.0001 and a 0.81. Improvement was evident as soon as day 1 at the first HMA assessment at week 1 and was maintained through week 12.

Panorama demonstrated similar results in 245 participants, The 100 microgram dose led to a 5.1 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. 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 DT21 program and 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 1 and sustained through week 12. Based on these results, FDA granted breakthrough therapy designation to DT-120 ODT for MDD, in addition to the previously granted therapy designation for GAD. In the completed double blind phases of all 3 studies, DT21 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. Treatment session dynamics were predictable and manageable.

Participants completed the standardized end of session checklist in an average of about 6 hours consistently across the studies. Our fourth Phase 3 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 3 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 DT21 in PTSD based on the clinical profile we have observed in GAD and MDD. We plan to enroll approximately 200 participants with change in the clinician administered PPSC scale for DSM 5 or CAPS-5 at week 8 as the primary endpoint.

As our DT21 clinical program advances, we are expanding our already substantial medical affairs team, including our field based medical science liaisons who engage with health care professionals to learn about and educate on the burden of disease the emerging treatment landscape, and the growing body of evidence supporting DT21. 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 DT21's potential role in treating anxiety and depression. Turning to DT402 for ASD. Our Phase 2a 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 5 participants. 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 is 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 multiday 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. Taken together, the breadth and consistency of the DT21 data and the positive initial DT402 findings position Definium with both a potential near term commercial product and a promising second asset. I will now turn the call over to Matthew. Matthew?

Matthew Wiley: Thanks, Daniel. The strength and consistency of the DT120 data allows us to plan for launch with an 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 DT21. 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 to 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 DT21 available, it is 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 27. 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. The important takeaway is that we are moving beyond commercial planning and putting our strategy, infrastructure, and capabilities in place for potential launch. I will now turn the call over to Brandi for our financial results.

Brandi L. Roberts: Thank you, Matthew. As of 09/30/2026, cash, cash equivalents and investments were approximately $1.05 billion compared with $412 million as of 12/31/2025. 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 and D organization and increased spending on the DT21 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. 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 continue 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 warrant, 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. We intend to use that advantage. With potential indications in GAD and MDD 2 of the largest areas in psychiatry, and no new treatment approved for GAD in 20 years we believe the opportunity for DT21 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 DT21 and creating value for patients, providers, and shareholders. With that, I will turn the call back over to Robert.

Robert Barrow: Thanks, Brandi. The progress we reported today reflects years of scientific rigor and disciplined execution. We have 3 positive Phase 3 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 27. 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 are closing out 2026 with exceptional momentum. And over $1 billion to invest in delivering on this vision.

I wanna thank the patients, investigators, employees, and partners whose commitment has made this progress possible. I look forward to sharing further updates as we progress in 2027 and beyond. With that, happy to take your questions.

Operator: Thank you. At this time, please press 11 on your telephone keypad. If your question has been answered or you wish to remove yourself from the queues, simply press 11 again. Again, if you have a question or comment at this time, please press 11 on your telephone keypad. To allow us to get as many analysts as possible, please limit yourself to 1 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 Tess Romero from JPMorgan. Your line is now open.

Analyst: Hi, Robert and team. Thanks much for taking our questions this evening. Just 1 from us. Are you able to opine on if the pre NDA meeting has taken place for DT21 ODT or if not, when it will, And how do you plan to share the outcome of this meeting? And will this come after your meeting minutes are received? Thank you.

Robert Barrow: Hey. Thanks so much for the question, Tess. Yeah. 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 and over the past several years and certainly over the past several months since we have had phase 3 data, As you suggested, once we have meeting minutes in hand is typically when we are in a position to share details for meetings because we do not wanna get ahead of ourselves or anything.

But again, that constructive dialogue we have had on an ongoing basis is it 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.

Analyst: Hey, guys. This is John on for Andrew. Thanks so much for all the updates. So with COMP360 to be approved in launched in the first half of 27, maybe just talk through some of the things you will be monitoring closely for the launch to potentially help inform your own launch for DT21, which could happen I guess, in about a year from now potentially. So is there anything you will be looking to glean specifically that is unique to COMP360? Perhaps even different from Spravato?

Robert Barrow: Yeah. Thanks so much for the question, John. You know, I think at the highest level, we are, 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 be delivered. So we will obviously, there is so many patients in such great need, and we feel really confident about the profile of DT120. We are gonna be following everything closely and obviously have our own thoughts, plans, strategy around how to get this out in the most impactful way.

So certainly gonna be watching and trying to position ourselves to be in position to launch as effectively and broadly as possible. For every 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.

Analyst: Hi. Thank you for taking my question. 1 quick 1. So 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 is 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. that is it.

Robert Barrow: Thanks so much for the question. And it is 1 that in terms of filing strategy, once we are 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. And as we think about both of these, you know, very important, very large indications, we are focused on driving the most efficient path to market and having the highest quality evidence we are able to behind it. So.

And we are really encouraged by momentum with the ASCEND study. it is only picked up since we had MDD data from EMERGE earlier in the year, and in terms of the sequencing and the ability and the data that would be submitted at various points in a review cycle, We will reserve any specifics there until able to talk holistically about the overall filing strategy. But suffice it to say,, we are 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.

Matthew: 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 are thinking about the MDD market? Thank you so much.

Robert Barrow: Yeah. Thanks so much for the question. Fundamentally, no. I am happy to ask Matthew Wiley to elaborate further. But, you know, we are, of course, of the field very closely. We feel very, very comfortable with the positioning of our product and ability to meaningfully differentiate from the psilocybin products and be in a great position. But, Matthew, I do not know if you wanna add any specifics there.

Matthew Wiley: Yeah. I would just go back to previous statements that I have made about the pricing corridor that payers have advised us they see the pricing corridor here somewhere between the $30 thousand to $75 thousand I think, currently, pay for SPRAVATO. As Robert said, there is differentiated value here And as we have payer discussions in the future, we will be able to narrow that corridor, but we feel pretty good about the feedback we have gotten so far. Thank you.

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

Mark: Daniel, 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 know, a little more well versed on with MDD and GAD. Thanks. If there are any.

Robert Barrow: Yeah. Daniel, you wanna go ahead and take that 1?

Daniel Rollings Karlin: Yeah. Sure. And thanks for the question, Mark. We are excited about PTSD. And while each indication has its own unique patient access challenges and things like this. We do not fundamentally think that this is gonna be in any way more difficult than what we have done already. So we have a lot of confidence in the asset and a lot of confidence in our clinical development team that is gotten us as far as they have and our clin ops folks as well and so just. We are 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. Sorry. Can you hear me? We can hear you now, ma'am. Go ahead.

Analyst: Oh, perfect. Hey. This is Yashan on for Gavin. We were just wondering on DT402, could you maybe expand on why you stopped enrollment after 5 patients and what you saw that kind of gave you confidence to move into the multiple dose study? And then was that decision based on prespecified stopping rules or a kind of review of the emerging data? Thank you.

Robert Barrow: Thanks so much. I will turn it over to Daniel to elaborate initially. Happy to add anything, Daniel?

Daniel Rollings Karlin: For sure. Yeah. So with 402 in the study, we have just wrapped up, the goal from the outset there was to look for what we would call early signals of efficacy. So this was a single dose open label study looking at drug response parameters over the course of that single dosing day. And what we had decided from the outset was that if we saw a strong and consistent signal that we would stop when we did not think there was more to be learned from the study.

So 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. And we have a lot of confidence moving forward from here.

Operator: Thank you. Next question or comment comes from the line of David Amsellem from Piper Sandler. Your line is open.

David Amsellem: Hey, thanks. So another question on 402, 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 are looking for, like social engagement, and what you are going to be incorporating in terms of outcome measures in the multidose trial? And then 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 gonna have to be monitored relative to what is been incorporated and what you are seeing for 21. Thanks.

Daniel Rollings Karlin: Yeah. it is an excellent question and 1 that has some open questions built into it. The historical Vineland scale that is been used for ASD does have a explicit social communication subscale. So using older established scales is gonna be very much on the plan. But we are 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 have seen so far.

So we will 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, there is some white space there. And we as folks who are quite interested in measurement and the best way to get at the kinds of questions we would like to ask of the drug. We will engage in a collaborative process with all stakeholders in the autism community and the regulatory community to be sure that we are 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.

Analyst: Hi, everyone. This is Gavin on for Brian. I just wanted to go back and ask a follow-up on some of the updates from Usona. So just given the potential NDA filing that they have had, given that they have a priority review voucher, we will 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 are kind of thinking about positioning MDD as well. Are you is there maybe a chance to wait until.

Wait to see how Usona filing might play out to see if whether you might also be able to file on a single and large phase 3 pivotal trial as well. Just wondering your kind of thoughts on that overall.

Robert Barrow: Yeah. Thanks so much, David. 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. And so. And we are obviously always looking at things that are happening with other programs and the regulatory framework and all of that. We have 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 is a really urgent need out there.

So 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. But we will watch, and we will see, but it is not gonna really change the course. We believe we have the right path ahead, the right strategy, and we are gonna 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 François Brisebois from LifeSci Capital. Your line is now open.

François Brisebois: Hi. Thanks for the question. I was wondering if you could, this a little further on Mark's previous question on PTSD. If you could just help us understand a little bit more of the CAPS-5 and why week 8 is the right week. To test drugs in this space.

Robert Barrow: Yeah. Thanks, Frank. I will turn it over to Daniel to cover that 1 as well.

Daniel Rollings Karlin: Yeah. The CAPS is a clinician assessed regulatorily acceptable measure of PTSD that is been used by pretty much everyone in the field even based on the newest definition of PTSD from DSM 5. Week 8 has real regulatory precedent as well, so that is why we are going with week 8. We will still have our full 12 week double blind period just as we have in our other studies. We will have data from out to week 12 in a double blind fashion.

But given our ability to move all of the scales that we have used as our primary move the MADRS and the HAM-A, we remain extremely confident that any scale that is reliable clinician assessed scale of the disease state we are likely to have efficacy, and that will not be a problem for us. So a lot of confidence heading into this PTSD study.

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

Matthew Hershenhorn: Hey, guys. Congrats on the amazing year, and thanks for taking our question. So 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 DT21 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.

Robert Barrow: Yeah. Thanks so much, Matthew. I mean, I think 1 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. And so we are already very much focused on that population, the ability to broaden out access and, you know, be able to deliver this to as many patients as potentially benefit from it.

As we think about PTSD in particular and as we think about, get. also, I think, even more importantly, getting DT21 potentially out in the world, we are very much engaged with the VA, with a number of stakeholders and connected to that care setting as well. And we will remain so. We wanna be at the forefront of every 1 of these with every 1 of these communities, and of the opportunity as well is broadening out indications to have the opportunity if we are successful in all 3 programs, to have both anxiety, depression, and PTSD eventually on the label.

That just gives us a really what we think, an appropriately broad entry point to try to benefit as many patients as we can. So, Daniel, I do not know if you wanna elaborate at all on some of the early work with the VA.

Daniel Rollings Karlin: Yeah. I mean, like Robert said, we really value the relationship we have had with the VA as a 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, so 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 is a relationship.

We will continue to foster as we move along.

Matthew: 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.

Sumant Kulkarni: Assuming 120 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. Yeah. that is it.

Robert Barrow: Thanks so much, Sumant. I think initial pass certainly can ask Matthew 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? So the opportunity to really represent, something brand new in terms of any sort of treatment 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.

And so both have unique characteristics that can shape that uptake curve. We feel very excited about both of those independently and, especially together, the opportunity to potentially, have an something that could help with both anxiety and depression is really encouraging, really exciting for us. But, Matthew, if you want to elaborate on that at all.

Matthew Wiley: Yeah. I will just make 1 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 last year. Is that those that have been failed by multiple therapeutic regardless of indication, those patients have a higher likelihood of trying So those patients can fail by 5 or more medications, 55% of them. Indicated that they would like DT21. So throughout the point, we do not really see a differentiation by indication. We actually see that patients in need are highly likely to try. Thank you.

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

Pete Stavropoulos: Hi, Robert and team. Congratulations on the quarter. With regards to the study design for PTSD, mainly patient selection. You know, PTSD is heterogeneous in terms of trauma exposure, chronicity. You know, psychiatric comorbidities. You know, are there any particular patient characteristics that you believe could have a strong. could lead patients to have a stronger response to 120? And how might those inform the enrollment criteria? And would you focus on this as a as a monotherapy, or will you move forward with patients on standard of care?

Robert Barrow: Yeah. Thanks so much, Peter. I will turn that 1 over to Daniel as well.

Daniel Rollings Karlin: Yeah. Thanks for the question. So 1 of the strengths of DT21 in particular is that, again, as we have shown now in GAD and MDD, we seem to be able to demonstrate efficacy across a range of heterogeneous populations. And so as compared to something with a much narrower mechanism, the ability to be a little more agnostic as to the finer grain nature of the patient presentation. And of course, limit comorbidities as we have in prior studies to people with histories of, you know, mania or psychosis But beyond that, once we get into the moderate to severe category of PTSD, we are going to take a pretty broad swath of that population.

So, you know, normal drug development limitations on medical comorbidities and things psychiatric comorbidities, and we fully expect to run these studies as a monotherapy as we have in other indications. If that is 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 drug groups are ultimately, the account is used to add parts of polypharmacy sometimes to a fault. And we intend to continue to demonstrate our primary evidence as monotherapy while demonstrating that the drug can be used safely. As a component of multidrug strategy. Awesome. Thank you for answering my question.

Operator: Thank you. Next question or comment comes from the line of Christopher Chen from Baird. Your line is now open.

Analyst: Hi, everyone. Thanks for taking my question. Congrats on the successful quarter. Just 1 turning back to 120. As you have had more time to dig into the data across the 3 trials there, Can you share any updates on how patient profile may be impacting response and remission rates? And are you able to point to any key drivers that may be separating those responders from nonresponders and remitters from nonremitters? Thank you.

Robert Barrow: Yeah. Thanks so much for your question, Christopher. And that. it is really an exciting 1. As more unfold 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, you know, we are always interested in trying to understand baseline characteristics that could predict response. But 1 of the really interesting findings is a really related to response patterns and treatment dynamics and what we can learn over the course of treatment.

So we continue to accrue data from part b of the studies and continue to further elucidate the response patterns of those patient pathways across the course of the entire year. And as we are able to share more specifically. You know, I think we are. Some 1 of the really, really interesting and potentially quite valuable insights that we will be able to share. So little bit early for me to answer fully, but, again, great question, and 1 that we are we are very much eager to get out there in the world here in the not too distant future.

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

Patrick Trucchio: Thanks. Good afternoon, and congrats on all the progress. And 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 BT 21 expanding beyond here clearly understanding we have a quite a large patient population with the existing indications. But I am just wondering, you know, based on the data you have seen, where you think maybe there is potential longer term?

Robert Barrow: Yeah. it is it is a great question. Thanks, Patrick. You know, we are premature to talk specifically about which indications we will be or would be pursuing in the future. But you know, 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, that we can broaden out in those other populations that are just especially those that are somewhat distinct either diagnostically or symptomatically from what we are treating today.

And certainly thinking also in the future about where we can go to broaden out the population and be clear about who all and inside of GAD and MDD and PTSD could benefit and how they could benefit. So something that we are we are very actively engaged in and thinking about for the future and as we get to refinement of those plans and clear path for potential expansion and other indications, we will 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 and Company. Your line is now open. Your line is now open.

Analyst: Hi. This is Peyton 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? And what do you believe will be needed to drive patient and physician awareness and drive patient flow to these clinics? And do you also believe that the uptake for MDD may be faster than GAD? Thank you.

Robert Barrow: Yeah. Thanks so much for the question. When we think about these indications, we really do not think about them as entirely independent from 1 another. And that would be sort of odd to do so given the high degree of overlap. So again, some of the sort of 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. And so again, there is quite an interplay there between the lack of available treatments and the prescribing and treatment patterns.

But when we think about the opportunity, we think about it pretty holistically and encompassing both those GAD and MDD patients together. Matthew, I do not know if you wanna add any further specifics in terms of how we think about No.

Matthew Wiley: The only other point I would add is on referrals and referral networks. For these clinics, There are some that are established now. But it is incumbent on us to build the story in the psychiatrist offices. So they are aware of DT21 if approved, and that the. 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 1 of these clinics. There are GAD patients in the clinics today being treated. We know that from data better than half of these BRAVATO patients by our calculations. Also have comorbid GAD, so they are being treated.

But there is a lot of good work ongoing to map out those referral networks and to ensure that they have great information at launch if we are approved.

Operator: Thank you and Thank you. Our next question or comment comes from the line of Rudy Li from Wolfe Research. Your line is now open.

Analyst: Hey. Thanks for taking my question. Can you provide additional color on the end of session checklist for DT21? Maybe just talk about the corner cases for patients who need to stay longer than 8 hours?. Usually, what will be the key limiting step or items and how to handle these cases in practice?. Thank you.

Robert Barrow: Yeah. Thanks so much, Rudy. You know, we feel really comfortable both in terms of the data we are seeing in the studies, in terms of our engagement with clinicians and the viability of the DT21 profile in those settings. So you know, 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 have yet to be able to share fully in terms of those data over time.

And we also again, in all of our engagement with sites who are providing care today have yet to see any real concern. there is some anecdotes from some of the studies where for instance, some of the edge cases and 1 in particular a patient fell asleep and the site decided not to wake them up. For a couple of hours. And as such, we had to report it out as being longer than an 8-hour monitoring. But then, of course, in the real world, if someone is asleep and like, wants to keep them there and let them sleep it out, then that is perfectly fine.

They have the discretion to make that decision, but we are 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. Thanks for the color. Very helpful. Thanks, Rudy.

Operator: Thank you. I am 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.

Robert Barrow: Thank you all for joining us again today. it is been incredibly exciting year and incredibly exciting quarter, and 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 DT21, or the opportunity to really have a profound impact on the field of psychiatry. So thank you again for being here and for all the support along the way. 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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