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DATE

Thursday, May 7, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

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

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TAKEAWAYS

  • DT120 ODT Phase III Clinical Progress -- Four ongoing Phase III studies across major depressive disorder (MDD) and generalized anxiety disorder (GAD); MDD study EMERGE has completed enrollment with 149 participants and will report topline results later this quarter.
  • GAD Study Enrollment -- Enrollment in VOYAGE (214 participants) is finished and PANORAMA has surpassed its target with over 200 enrolled, with topline VOYAGE data expected early in Q3 and PANORAMA late in Q3.
  • Study Powering Assumptions -- VOYAGE and PANORAMA are powered at 99% or greater to detect a five-point placebo-adjusted difference, with blinded analyses conducted at 12 weeks; EMERGE is powered at 80% for the same differential on a six-week endpoint.
  • Durability and Endpoint Design -- Phase III trials evaluate the durability of a single DT120 ODT administration for at least 12 weeks and will track retreatment intervals through one year in Part B across all pivotal studies.
  • DT402 ASD Program -- The DT402 program advances through a Phase II signal-of-efficacy study in autism spectrum disorder (ASD), focusing on novel patient- and observer-reported outcomes as well as digital behavioral markers.
  • Commercial Opportunity -- Management estimates that 1% penetration of the target addressable market for GAD and MDD, totaling 4.2 million unique U.S. adults, could represent a $2 billion annual revenue opportunity at Spravato reference pricing.
  • Q1 2026 Research & Development Expense -- R&D expenses were $41.5 million, up by $18.1 million, driven primarily by a $15.2 million increase in DT120 program costs, $3.2 million from personnel, $300,000 in DT402 costs, and offset by a $600,000 reduction in preclinical and other expenses.
  • Q1 2026 General & Administrative Expense -- G&A expense totaled $17.7 million, an $8.9 million increase due to higher stock-based compensation ($3.9 million), personnel ($1.4 million), commercial preparedness ($1.4 million), corporate/government affairs ($1.4 million), and legal/patent costs ($1.2 million), offset by $400,000 in miscellaneous reductions.
  • Q1 2026 Net Loss Components -- Net loss was $77.1 million, including a $20.0 million non-cash increase from the rising fair value of a 2022 USD financing warrant, reflecting the share price move from $13.39 to $18.90 during the period.
  • Balance Sheet and Runway -- Cash, cash equivalents, and investments stood at $373.4 million, which management states is sufficient to fund operations through multiple clinical readouts and into 2028.
  • Regulatory Engagement -- DT120 holds Breakthrough Therapy designation for GAD and management reports a constructive FDA relationship, aiming to expedite NDA filing upon positive pivotal data.
  • DEA Scheduling Change -- CEO Barrow stated, "If implemented and DEA could as a result make a decision on scheduling at the same time as an NDA approval, that could save roughly 90 days, which is the current timeline to an interim final rule and issuance of the schedule for an approved product."

SUMMARY

Management confirmed three pivotal data readouts for DT120 ODT across MDD and GAD are scheduled in the coming quarters, with trial enrollment and powering parameters transparently detailed in the call. Company leadership stressed that all studies evaluate single-dose durability and will inform both regulatory labeling and future retreatment guidance via extended patient follow-up. A transition to central nervous system indications such as PTSD and ASD was reiterated, with explicit reference to Phase II progress for DT402 in ASD and a new trial for DT120 in PTSD scheduled for 2027.

  • Chief Commercial Officer Wiley explained that the 1% market share estimate for the company’s lead indications already accounts for diagnostic overlap, stating, "The 4.2 million patient number I cite includes those with both diagnoses—these are unique patients we have identified, all 18 and over—so the TAM accounts for overlap; dual-diagnosis patients are deduplicated."
  • Chief Medical Officer Karlin clarified that open-label retreatment thresholds in MDD are set at the mild-to-moderate boundary on the MADRS scale because "that level is where clinicians would consider initiating or re-initiating medication at all," reflecting clinical input received during study design.
  • CEO Barrow stated that capacity constraints for rapid DT120 adoption are minimal: "setting up a treatment room is straightforward: have a room and someone who can be present for an extended period in a current facility. That is enough. There is not a substantial financial or logistical bottleneck—“infrastructure” is too heavy a word."
  • Management indicated positive regulator and payer engagement, with ongoing discussions specific to monitoring requirements for REMS programs, insurance coding and reimbursement readiness, and U.S. Drug Enforcement Administration scheduling changes impacting market timing.

INDUSTRY GLOSSARY

  • MADRS: Montgomery-Åsberg Depression Rating Scale; a clinician-administered scale used to assess depression severity, frequently applied as a primary endpoint in MDD clinical trials.
  • HAM-A: Hamilton Anxiety Rating Scale; a commonly used clinician-reported outcome for assessing anxiety levels in GAD studies.
  • CAPS: Clinician-Administered PTSD Scale; a gold-standard structured interview used for evaluating the severity of PTSD symptoms in clinical trials.
  • J-code: A reimbursement code used by Medicare and insurers in the U.S. to facilitate billing for drugs administered in a clinic or physician’s office.
  • REMS: Risk Evaluation and Mitigation Strategies; FDA-mandated programs to manage known or potential risks associated with certain medications, sometimes requiring specific procedures or monitoring.
  • Open-label extension (OLE): A study phase following a randomized trial where all participants can receive the investigational treatment, often used to collect long-term safety or retreatment data.
  • Part B: The post-randomization, open-label extension periods for DT120 studies, enabling up to four triggered retreatments based on symptom recurrence, supporting long-term safety and real-world use data.
  • Spravato: Brand name for esketamine nasal spray, referenced as a pricing and reimbursement surrogate for market modeling, approved for treatment-resistant depression.

Full Conference Call Transcript

Gita Jain: Good afternoon. I am Gita Jain, Head of Investor Relations, and thank you for joining us today for Mind Medicine (MindMed) Inc.’s first quarter 2026 financial results and recent highlights conference call. Currently, all participants are in listen-only mode. This webcast is live on the Investors section of Mind Medicine (MindMed) Inc.’s website at definiumtx.com, and a replay will be available after the webcast. Leading the call today will be Robert Barrow, our Chief Executive Officer, who is joined by Daniel 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 be making certain forward-looking statements including, without limitation, statements about the potential safety, efficacy, and regulatory and clinical progress of our product candidates, our anticipated cash runway, and our future expectations, plans, partnerships, and prospects. These statements are subject to various risks such as changes in market conditions, and difficulties associated with research and development and regulatory approval processes. These and other risk factors are described in the filings made with the SEC and the 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 assumptions, opinions, and estimates of management at the date the statements are made, including the nonoccurrence of the risks and uncertainties that are described in the filings made with the SEC and the applicable Canadian securities regulators or other significant events occurring outside of Mind Medicine (MindMed) Inc.’s normal course of business. You are cautioned not to place undue reliance on these forward-looking statements which are made as of today, 05/07/2026. Mind Medicine (MindMed) Inc. disclaims any obligation to update such statements even if management’s views change, except as required by law. With that, let me turn the call over to Robert Barrow. Thank you, and thank you all for joining us today.

Robert Barrow: 2026 marked a strong start to what we believe will be a pivotal year for Mind Medicine (MindMed) Inc. We remain highly focused on disciplined execution as we have advanced our late-stage clinical programs, prepared for multiple near-term data readouts, and continued to build an incredible team to lead our potential commercialization efforts. As we discussed at our Investor and Analyst Day a few weeks ago, Mind Medicine (MindMed) Inc. is entering a period of meaningful clinical inflection. Our lead program, DT120 ODT, is advancing with four ongoing Phase III studies across major depressive disorder (MDD) and generalized anxiety disorder (GAD), with topline data from EMERGE expected later this quarter, followed by VOYAGE and PANORAMA in the third quarter.

Our Phase III programs are designed to evaluate outcomes that we believe represent a meaningful advance for patients, physicians, and the field of psychiatry. These include not only the magnitude of symptom improvement, but also safety, tolerability, and durability of response following a single administration—dimensions we believe will be critical in differentiating DT120 ODT in today’s treatment landscape. We are also encouraged by the increasing recognition of the significant unmet need in these indications. With three Phase III readouts anticipated across two of the largest indications in psychiatry, Mind Medicine (MindMed) Inc. is approaching an important moment for the company and for the patients we aim to help.

With Breakthrough Therapy designation for DT120 in GAD, we have established a constructive working relationship with FDA and will move as efficiently as possible towards an NDA submission, subject to positive pivotal data. Beyond our ongoing Phase III programs, we plan to expand development of DT120 ODT into additional indications including post-traumatic stress disorder (PTSD), with the planned initiation of our HAVEN study in 2027. We believe this represents an important opportunity to further leverage the potential of DT120 across areas of high unmet need.

Overall, we continue to believe in DT120 ODT as a potential best-in-class product candidate—one that could help redefine what is possible for the millions of people living with depression, anxiety, and PTSD who remain underserved by existing treatments. I will now turn the call over to Daniel Karlin to go into more detail on our clinical programs. Daniel?

Daniel Karlin: Thanks, Robert. I will provide an update on the status of our clinical programs with a focus on where each of our late-stage studies stands today and how those studies were designed to assess what we believe would constitute a clinically meaningful outcome. Starting with DT120 ODT, our lead program continues to advance across Phase III studies in MDD, GAD, and now PTSD. In EMERGE, our first Phase III study in MDD, enrollment is complete with 149 participants. We are now in the final stages of trial execution and data preparation and we remain on track to report topline results later this quarter. In GAD, we are rapidly approaching topline data readouts for our two pivotal studies, VOYAGE and PANORAMA.

Enrollment in VOYAGE is complete with 214 participants. We have exceeded our updated enrollment target of 200 in PANORAMA and expect to complete enrollment this month. We continue to expect topline data from VOYAGE early in the third quarter and PANORAMA late in the third quarter. Across our pivotal program, our focus has been on rigorous execution, data quality, and consistency across studies and sites. These are large, well-controlled trials designed to evaluate the magnitude of improvement alongside safety and durability of response following a single administration of DT120 ODT.

Given our confidence in the clinical profile of DT120 and the strong evidence we have generated to date, our approach is uniquely designed to establish the durability of a single treatment for at least 12 weeks. Our Phase III studies in MDD and GAD were initially powered to detect a placebo-adjusted difference of five points. As part of the protocol-specified design, we conducted sample size re-estimations in VOYAGE and PANORAMA. These analyses were performed without unblinding treatment assignments and were intended to assess key nuisance parameters—standard deviation and dropout rates—to support the maintenance of the intended statistical power.

Based on these blinded analyses, which were conducted when half of participants reached the 12-week time point, VOYAGE and PANORAMA are now powered at 99% or greater to detect a five-point placebo-adjusted difference, assuming these nuisance parameters remain consistent in the final study analysis. For EMERGE, the study was powered at 80% to detect a five-point placebo-adjusted change, with statistical significance expected at a little over a three-point difference based on certain nuisance parameter assumptions. We selected this level of power intentionally, as we believe a three-point or more difference represents an appropriate threshold for clinical meaningfulness in MDD.

It is also worth noting that EMERGE has a six-week primary endpoint compared to 12 weeks for VOYAGE and PANORAMA, mitigating the risk of an elevated dropout rate in the primary analysis. Additionally, while the studies were powered to detect a five-point difference, we believe that a placebo-adjusted improvement of four points or greater at six to 12 weeks after treatment would compare favorably to currently available treatments for GAD and MDD and other product candidates in the psychedelic category. Durability remains a particularly important dimension for psychedelics. In our Phase II program in GAD, DT120 demonstrated durability through 12 weeks following a single administration of 100 micrograms.

Our Phase III trials are designed to further evaluate consistency and duration of response over time. Through Part B of these studies, patients are followed for up to one year, which we believe will provide important information to inform potential labeling, including how frequently treatment may be needed. Beyond DT120, we are excited to also be advancing our Phase II study of DT402 in autism spectrum disorder (ASD). DT402, the R-enantiomer of MDMA, has shown promising prosocial effects with a potentially favorable tolerability profile. We are developing DT402 to target the core characteristics of ASD, specifically addressing social communication that is central to the experience of the disorder.

We see this program as a significant opportunity given the high unmet need, the increasing prevalence of ASD, and no FDA-approved therapies that specifically address these core characteristics. As we look ahead, the next five months represent a significant culmination of thoughtful trial design, disciplined execution, and years of work focused on addressing some of the most pressing unmet needs in psychiatry. With multiple Phase III readouts approaching, we believe we are well positioned to deliver decisive data on DT120. I will now turn the call over to Matthew Wiley to discuss our commercial strategy and the broader treatment landscape. Matthew?

Matthew Wiley: Thanks, Daniel. I will spend a few minutes discussing the commercial opportunity for DT120, building on what we shared at our Investor and Analyst Day in April. As we discussed, GAD and MDD represent very large and persistently underserved markets. Many existing medicines are constrained by delayed onset, partial or inconsistent efficacy, and tolerability issues that drive high discontinuation rates. Across this landscape, roughly 4.2 million U.S. adults have cycled through two or more treatments without the same benefit—a population that sits at the center of our initial launch focus.

We believe that these patients and the physicians treating them are actively looking for a next-generation option that works differently and can deliver durable improvement without the need for chronic daily dosing. To put the scale of this opportunity in perspective, and using Spravato’s average annual price as a surrogate, capturing just 1% of the total addressable market in these indications represents potential for roughly a $2 billion annual revenue opportunity. Our targeting model is built directly around the substantial unmet need. We have identified high-volume health care practitioners—primarily psychiatrists and psychiatric nurse practitioners—who manage concentrated populations of these specific patients.

These high-volume prescribers are located within psychiatric behavioral health networks and select integrated health systems where these patients most often receive care. We have mapped these priority targets in detail and plan to focus our launch efforts on engaging these clinicians, particularly those who have experience with or have expressed interest in novel in-office interventions and are supported by care teams capable of monitoring patients during the dosing day. We believe this approach will enable us to reach a meaningful number of appropriate patients from the outset, while establishing a strong foundation for scalable adoption. One of the points we highlighted at our Investor and Analyst Day is the growing awareness of DT120 among clinicians.

Through ongoing engagement, we have seen increasing familiarity with its clinical profile and strong interest as a potential new treatment option that could help patients move beyond therapies that are no longer providing adequate or lasting relief. We also shared data showing that patients discontinue current treatments at a high rate, often due to lack of efficacy or tolerability. These challenges are especially pronounced among patients who have been failed by two or more prior therapies, reinforcing the substantial need for differentiated innovations like DT120. Our commercial strategy is shaped by these realities.

We are focused on how this therapy can be introduced in a way that is scalable, accessible, and practical within real-world care settings without the necessity of chronic interventions. A key element of our planning includes a centralized hub support model and additional field support to enable a frictionless process of adoption and delivery. In parallel, we continue to engage with physicians, payers, and other stakeholders to better understand decision drivers around adoption, patient identification, and reimbursement frameworks. By pairing a well-articulated unmet need in a receptive market with our disciplined, patient-centric commercial strategy, Mind Medicine (MindMed) Inc. is very well positioned as we near pivotal data readouts and advance DT120 toward potential commercial launch.

With that, I will turn it over to Brandi to discuss our financial results.

Brandi L. Roberts: Thanks, Matt. Before walking through our financial results, I want to briefly set the context for how we are thinking about capital deployment as we move through an important phase for Mind Medicine (MindMed) Inc. As we entered 2026, we were pleased to have the financial flexibility to accelerate several key initiatives in parallel, including ongoing Phase III execution, NDA preparation activities, market access priorities, and continued engagement with key opinion leaders and leading practitioners. These investments are intended to support our path forward and, if DT120 is approved, position the company to be well prepared for a robust, thoughtful commercial launch.

We have also been encouraged by the continued evolution of our investor base in 2026, with strong engagement from existing shareholders and growing interest from new investors as we made progress across our program. We believe this reflects increasing recognition of the opportunity ahead as well as confidence in our disciplined approach to execution and capital allocation. I will now turn to our financial results for Q1 2026, which are detailed in the earnings release we issued this afternoon. Research and development expenses were $41.5 million compared to $23.4 million for Q1 2025.

The net increase of $18.1 million was primarily driven by an increase of $15.2 million in DT120 program expenses, $3.2 million in internal personnel costs as a result of expanding our R&D capabilities, and $300,000 in DT402 program expenses, partially offset by a $600,000 reduction in preclinical and other program expenses. For Q1 2026, general and administrative expenses were $17.7 million compared to $8.8 million for Q1 2025.

The net increase of $8.9 million was primarily due to $3.9 million in stock-based compensation expenses, $1.4 million in personnel-related expenses, $1.4 million in commercial preparedness-related expenses, $1.4 million in corporate and government affairs expenses, and $1.2 million in legal and patent expenses, partially offset by a $400,000 reduction in other miscellaneous administrative expenses. The year-over-year increase in G&A expenses reflects deliberate investment to support a more mature organization as we prepare for our anticipated Phase III topline data readouts and potential commercialization. Overall, our R&D and G&A expenses for the first quarter were in line with our internal expectations as we continue to make meaningful progress across the DT120 and DT402 programs.

Net loss for Q1 2026 was $77.1 million compared to $23.3 million for Q1 2025. As a reminder, our net loss can be significantly impacted by changes in the fair value of our 2022 USD financing warrant, which are marked to market each quarter. For Q1 2026, the impact on net loss from the change in fair value was $20.0 million, reflecting an increase in our share price from $13.39 at 12/31/2025 to $18.90 at 03/31/2026. Turning to the balance sheet, we ended Q1 2026 with $373.4 million in cash, cash equivalents, and investments. We believe our capital position provides sufficient runway to fund planned operations through multiple anticipated clinical readouts and into 2028.

2026 is shaping up to be a data-rich and strategically important year for Mind Medicine (MindMed) Inc. Our financial position allows us to remain focused on disciplined execution while maintaining the flexibility needed to support our priorities and continue building long-term value for shareholders. With that, I will turn the call back to Robert.

Robert Barrow: Thanks, Brandi. After years of thoughtful trial design and focused execution, we are entering a period of numerous pivotal milestones that we expect will define the next chapter for Mind Medicine (MindMed) Inc. and our broader field. As we mark Mental Health Awareness Month, the urgency of advancing new treatment options and the responsibility we carry for patients feels especially pronounced. Before we close, I want to say thank you to our incredible team, the investigators and their teams, and to the hundreds of patients who have made this work possible. We will now open the call for questions.

Operator: At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, you will need to press 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press 1-1 again. Our first question will come from the line now open.

Brandi L. Roberts: I am sorry, you cut out for a second. This is for Paul.

Operator: Yes, your line is now open, Paul.

Analyst: Hi. This is Emily on for Paul Matisse at Stifel. We just had a quick question assuming you have success in MDD and anxiety this year. Could you speak more to your thoughts around how much long-term safety and retreatment data you would need for approval? And in these long-term data, would patients need to retreat a certain amount of time to count as a long-term exposure for safety? Thank you.

Robert Barrow: Great, thanks so much, Emily. I will speak briefly to this and then turn it over to Daniel to elaborate. We have had a great dialogue with FDA over the past several years, obviously building towards an eventual plan for an NDA submission subject to positive data and all that has to happen to get ready for an NDA, which we are very well positioned for. In terms of safety data and what is required, we feel really comfortable with the completion of Part A and the data that we will have available at the time of filing and at various milestones between here and there. We have sufficient safety exposure, both single-dose and over longer periods of time.

Of course, the interesting dynamic with drugs that you do not have to take continuously or daily is that treatment patterns can diverge across different patient populations, which can mean that six months of treatment can look like one dose or multiple doses. That is something we are really interested in characterizing in our Phase III program. Regardless, we feel very well positioned with the studies we are conducting and that we will be in a great position to move forward, subject to positive Phase III data. Daniel, do you want to add any color?

Daniel Karlin: Yes. I will elaborate a bit on the value of the Part Bs of these studies where we are able to deliver triggered treatment based on people having moderate symptoms of GAD or MDD or worse—moderate or severe. The value is multifold. First, it helps keep people in Part A of the study; as you saw from our announced sample size re-estimation outputs, our dropout rates are remarkably low in part because people know that they have this opportunity, if they are still symptomatic, to get open-label treatment in Part B. The ability to follow folks long term for up to a year after their initial blinded dose is another advantage.

For folks who get to mild illness or better, we just get to keep watching them in that initial controlled, blinded state unless and until they get sick again, if they in fact do. Then, as Robert said, in those Part Bs we can give up to four additional open-label treatments contingent on people developing moderate illness or worse. That will give us the ability to carefully characterize across these studies the patterns of treatment that emerge when treating people with moderate or worse symptoms, which is pretty well aligned to what we think would likely happen in the real world if approved.

With all of those data in hand, we are confident that we will have everything we need to inform FDA and, of course, to inform the clinical and patient community if we do get approved.

Analyst: Great. That is super helpful, and congrats on the quarter.

Operator: Thank you. One moment for our next question. Our next question comes from the line of David Amsellem of Piper Sandler. Your line is now open.

Analyst: Thanks. Just a couple from me. One, in terms of the patient experience—patient monitoring—how confident are you that in practice only one dosing session monitor will be needed to monitor the patient? Sort of a REMS-related question on that front. And then I have a question on the PTSD HAVEN study. A little bit of color on the thought process behind running HAVEN as straight active versus placebo as opposed to including a low 50 microgram dose arm. Thanks.

Robert Barrow: Thanks so much, David. Daniel, I will turn it over to you.

Daniel Karlin: Great questions. In the clinical trials, per FDA direction, we have an in-person lead monitor and then a secondary monitor who can watch remotely via video. That has been the condition for conduct of clinical trials based on FDA direction. Throughout the trials, we have made every effort to collect regulatory-grade data on what those monitors are doing to provide assistance and comfort for the patients, up to and including what the role of that second monitor actually ends up being. All of this is in service of making the case that a single monitor is absolutely something that should be enabled in the real world. That is our position.

In the longer term, if you look at other therapies that have acute consciousness-altering effects, things like monitoring ratios have not been explicitly specified; at the end of the day, it is left to clinical discretion and clinical judgment to ensure that patients are safely monitored. Of course, there is some content in existing REMS, and we will expect to have content in our REMS that relates to monitoring, but it will adhere to the evidence we have established for what constitutes safety and efficacy. On PTSD: across the Phase III program, we have combined studies. We have studies with two arms, and in two cases we have added this lower-enrolling 50 microgram confounding arm.

That is not an analytical arm; it exists to confound the understanding of people in the other arms as to what they got. In each case for GAD and MDD, our first study in the condition used a two-arm design with an inert placebo, which we continue to believe is the appropriate control condition for testing psychiatric medications, including DT120 and any other psychedelic for that matter. That is what we did in PTSD. We think head-to-head is the best way to establish evidence of efficacy.

As we gather the accumulated evidence and as we are able to read out the evidence from these other three studies that we are conducting and ultimately from ASCEND, which we have guided is starting imminently, all of that will accumulate to help us understand what, if any, effect that 50 microgram dose arm has on the understanding of people in the other arms as to what dose of drug they got and whether they got a treatment dose or not, and also whether that has any effect on the measured outcomes.

As we gain more knowledge about the performance of these different studies with the different control and confounding conditions, that will allow us to think about future studies and their design. But for primary evidence of efficacy, we continue to believe head-to-head is the right control condition.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Andrew Tsai of Jefferies. Your line is now open.

Analyst: Hi. It is Brian Bolton here on for Andrew Tsai. Two questions. First, on patient journey: you mentioned Phase III with your five to eight hour patient journey versus 10 to 12 hours in Phase II. Can you talk about what gets you closer to five hours as opposed to eight? What do you need to establish with the FDA and sensors to make it happen? And secondly, your placebo responses in the GAD study were higher compared to other GAD studies. How are you thinking placebo might trend in the Phase IIIs, and then same for the Phase III MDD study as well? Thank you.

Robert Barrow: Thanks so much, Brian. On the first question, some of the changes we highlighted a few weeks ago at our event include formulation—using an orally dissolving tablet in our Phase III program where we see faster absorption that we think could translate into a better profile in terms of resolution of symptoms. Our approach has been intentional from day one. Going into our Phase II program, we included a higher dose, 200 micrograms, and therefore, appropriately conservatively, extended the monitoring period in Phase II up to 12 hours and had an extremely lengthy set of criteria measured to assess when patients could end the monitoring session.

Based on learnings and data from the Phase II study, we made revisions to the formulation and to that end-of-session checklist. In Phase III, we feel confident we are moving in a shorter direction, and that is what we are seeing so far. In addition, the change from a 12-hour monitoring period to an eight-hour monitoring period being required for all participants was driven by discussions with FDA and those data. We feel confident we are heading in the right direction there and that, regardless, within that window we see a very attractive clinical profile—one that means patients are not rushed and one that enables providers to have a low-turnover, high-efficiency delivery to patients.

On placebo response, we had a remarkably high placebo response in the Phase II GAD study. An 80% likelihood for patients to be receiving some dose of drug tends to drive up placebo response. We also saw that around a third of patients who received placebo guessed they were on drug, and the presence of several lower doses likely enhanced that placebo response. There were also dynamics with dropout—Phase II had nothing to offer patients beyond the initial dose—whereas in Phase III we have Part B and patients are guaranteed access to open-label drug if they continue through the 12 weeks.

As we look to Phase III, having a lower allocation ratio and having a reason for patients to stay in the study should reduce placebo, perhaps even below historical averages. That would be true in both GAD and MDD. We also see in other programs, including the pivotal studies for Spravato, lower placebo responses than historically seen for daily antidepressant studies. It would not be surprising if we saw lower-than-average placebo responses across the Phase III programs here. Given that we exceeded a high placebo by a wide margin in Phase II, we feel confident we will be in a great position heading into the Phase III data.

Operator: Thank you. One moment for our next question. Next question comes from the line of Mark Goodman of Leerink Partners. Your line is now open.

Analyst: Hi, good afternoon. This is Basma on for Mark. Thank you for taking our questions. First, about the PTSD program: can you remind us of your convictions regarding the dose you are using in PTSD? Why do you think it is going to be efficacious? And what are the study powering assumptions? Second, for submission in MDD or GAD—whatever comes next—can you leverage the safety data from GAD, or will you have to collect another set of exposure data in the relevant patient population? Thank you.

Robert Barrow: I will take the second one first and then turn it over to Daniel. We certainly expect to have exposure from pivotal studies and efficacy studies in any population we are conducting research in. ICH guidelines for patient exposures are not disease- or disorder-specific, so there is not a requirement to meet some huge population requirement by indication. Daniel?

Daniel Karlin: Great question about PTSD. Having done our dose-range finding study in Phase II and gaining great confidence in our Phase III dose—and dose in this formulation—through transitional PK work, we had the confidence to go forward in GAD and MDD and also in PTSD with that dose. From a symptomatic perspective, disease definition overlap, and scale overlap, all of those come into alignment, and there is no reason to think that the variations that make up these differently defined diseases—but that fundamentally have such tremendous overlap—would call for any additional dose adjustment moving forward. So we go into PTSD with the same confidence we went into MDD, with the dose we selected initially for patients with primary GAD.

From a powering perspective, we continue to look at a five-point change on the condition-relevant scale as a good sweet spot—HAM-A for GAD, MADRS for MDD, and CAPS for PTSD.

Operator: Thank you. One moment for our next question. Our next question comes from the line of François Brisebois of LifeSci Capital. Your line is now open.

Analyst: Hi. Thanks for taking the question. You talked about the overlap here. It seems like MDD is more episodic than GAD. In terms of probability of success, is there more confidence in one versus the other? And is there anything about the disease itself with GAD that could trigger a higher placebo response, or is this more from the trial design?

Robert Barrow: Thanks so much, François. I will turn that back over to Daniel.

Daniel Karlin: Great question. We have introduced new slides to look at the GAD–MDD overlap. In the vast majority of patients, it is something of a temporal distinction. If they have MDD, it is because they have had or are currently in a major depressive episode. Major depressive episodes by definition end—they have start and end points—whereas GAD is more of a constitutive background state of anxiety. The longer someone has high anxiety, the more likely they are to have a major depressive episode, and the more frequent and severe the episodes, the more likely they are to have high background anxiety. Historically, MDD has been an easier target for many classes of antidepressants than GAD.

In part, in MDD we are helping folks return to a state they have been in more recently, whereas with GAD we are pushing toward a state someone may not have experienced in a long time. That, in part, gives us great confidence in MDD. We also saw in Phase II that we were able to move the MADRS pretty dramatically in GAD patients despite them starting lower than typical MDD baselines—less room to move—and we still saw meaningful change. On placebo in GAD, it is more the design than the disease.

The five-arm design with an 80% likelihood of getting drug, together with lower-dose arms that may feel like something to someone, likely drove a higher actual placebo response and also a higher measured placebo response due to dropout and data replacement strategies.

Analyst: Thank you for that. And a quick one for Matt. You mentioned 1% penetration of the TAM equals about $2 billion. How do you handle the overlap of MDD and GAD to get to that number? And on the commercial side, any learnings from the J-code implications for Spravato and how that might have triggered sales?

Matthew Wiley: Sure. The 4.2 million patient number I cite includes those with both diagnoses—these are unique patients we have identified, all 18 and over—so the TAM accounts for overlap; dual-diagnosis patients are deduplicated. Regarding the J-code for Spravato, it gives us confidence that there is a path forward to submit for a J-code for DT120 as well. That is in our plans and an operating assumption to submit once we get into the market, if DT120 is approved.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Pete Stavropoulos of Cantor. Your line is now open.

Analyst: Hi. This is Samantha on the line for Pete. Thanks for taking our questions and congrats on the quarter. For the MDD OLE, you set the trigger for redosing at a MADRS score of 20 or greater. Could you help us understand why 20 was chosen and, through your market research, is that level of severity a threshold where health care practitioners would likely recommend another dosing session?

Robert Barrow: Thanks so much. I will turn it over to Daniel.

Daniel Karlin: Great question, Samantha. Across our studies, in Part B we set the threshold on the scale at the line between mild and moderate. While scale thresholds are psychometrically validated, they are still somewhat arbitrary choices. We chose the mild-to-moderate boundary because, in talking to a wide community of prescribers, that level is where clinicians would consider initiating or re-initiating medication at all, let alone a more intensive and likely expensive medication. That threshold also corresponds to where people start to accumulate functional deficits—symptoms become severe enough to interfere with activities of daily living such as school, work, and family.

That seemed a reasonable place to draw the line in studies and a likely threshold used clinically, though clinical judgment will rule in practice and these scales are not often used routinely due to administration burden. We expect that if clinicians assess functional deficits, that will push them toward using therapies like ours.

Robert Barrow: I will add one point, Samantha. While there is discussion about subgroups of MDD and TRD populations, the real driver of personal and economic benefit is improving severity. Finding patients with severe symptoms and improving them to a state with meaningfully improved function is why we set thresholds where we did, and why we are focused on severity rather than siloing into a small subset who failed two SSRIs.

Analyst: Very clear. Thank you. If I can sneak in one more: with interventional psychiatry increasingly integrated into practices and health systems, what preparations are underway at clinics to pivot and deliver DT120 operationally? What are you hearing in your commercial prep work?

Robert Barrow: Matt, over to you.

Matthew Wiley: Thanks, Samantha. Clinicians doing high volumes of interventions today have been preparing for psychedelics coming to market and are allocating space accordingly. We feel encouraged by the anticipation and receptivity of the market for these interventions as they make their way into practice. There is high anticipation for DT120, and the data we shared a couple of weeks ago highlight momentum and receptivity. Our targeting model prioritizes physicians who are receptive to the concept and who have the capability and capacity to accommodate patients for treatment.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Matthew Hirschenhorn of Oppenheimer. Your line is now open.

Analyst: Hey, guys. Congrats on all the progress, and thanks again for hosting us two weeks ago. As you talk to clinics, what are some of the economic incentives they have to modify capacity for DT120, especially considering moving away from Spravato? Do you see time-based reimbursement and less friction arising from patient turnover compared to Spravato as potential advantages? And perhaps if you have any estimate on how many clinics it would take to eventually treat 100,000 patients per year, considering likely capacity?

Matthew Wiley: Thanks for the question. Regarding practice economics, we recognize it is top of mind for physicians. We are building out clear direction on what will be available at launch and which codes we will secure post-launch to ensure physicians are adequately reimbursed for administration. Clinics have been allocating some space initially and anticipate judging market volumes to determine whether to allocate additional space. This will be determined as we get into the market. As we get closer, we will have more market research to share on expected volume and capacity both at launch and in subsequent years.

Analyst: Thank you. And one additional question on PTSD: any differentiated advantages for DT120 compared to other psychedelics—psilocybin and DMT specifically—for this indication? Any input or discussions with the VA, considering prevalence among veterans, informing enrollment criteria or data collection?

Daniel Karlin: One of the things we hear from sites about the characteristics of DT120 and the patient experience is that it is very well tolerated, particularly emotionally. People find the onset, plateau, and gentle return to normal consciousness to be well tolerated and pleasant in ways other drugs may not be. For folks with high levels of anxious arousal and hypervigilance in PTSD, that predictable and gentle experience—predictable onset and offset with adequate plateau time—may be advantageous. Regarding the VA, we have been working with VA researchers on our research to date. As we move into PTSD, we will continue to deepen and strengthen those relationships.

The VA’s expertise in PTSD will be important to the design and execution of those studies as it has been in our studies to date.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Sumant Kulkarni of Canaccord Genuity. Your line is now open.

Analyst: Good afternoon. Thanks for taking our questions. I have three. First, what are your latest thoughts on filing strategy? Would you file both GAD and MDD at the same time, or do you think GAD, which will have two Phase III readouts earlier, will be your first targeted indication?

Robert Barrow: Thanks, Sumant. We are having ongoing discussions with FDA around the appropriate strategy. We have also seen communication from FDA about thinking for filing on studies where there is a high degree of overlap. There is a long regulatory and legal precedent that, when there are highly overlapping indications, a single study may be supportive of expansion into that indication. Some of this will be contingent on how compelling the data are across the studies, particularly in MDD. If we see a smaller effect, we would have less compelling evidence than if there is an extraordinarily large effect that implies small studies might suffice to replicate. Ultimately it will be informed by the data and subsequent discussions with FDA.

We feel confident in the position for filing DT120, and regardless of concurrent or sequential filings, we think we will be in a great position to go after both markets, hopefully, and to get into the patient population if we are fortunate to get a drug approved.

Analyst: Thanks. Second, for Matt, on commercialization: both GAD and MDD present very large opportunities. Which one could prove more challenging to crack for DT120, and why?

Matthew Wiley: Thanks, Sumant. The unmet needs in both indications are high, and there is strong receptivity in our market research for both. Our targeting model and value proposition are aimed at both indications; we do not have a favorite. We believe many patients need help and need this treatment, and if approved with a dual indication, we will go after both with equal measure. Also, the diagnosis of GAD is not as reflective in claims data as MDD, simply because there have not been novel treatments in a couple of decades. We believe there is a lot of GAD that is underdiagnosed in ICD-10 data, and that could change with a therapeutic intervention that meets that need.

Analyst: Last one is almost a philosophical question. What are the real-world advantages and disadvantages of receiving a Commissioner’s National Priority Voucher?

Robert Barrow: It is a good question. Anything we can do to accelerate and be more efficient in development we are interested in. We have been moving at a lightning speed; we opened this IND less than about four years ago. We focus on what we can control: doing research the right way to move the program forward to pivotal data, which we have coming up very soon. What comes after that—with novel programs at FDA—there can be advantages and also potential risks. One important consideration for our program is the opportunity to potentially go after both indications. If we are in that position, there is a lot to navigate regarding which indication might benefit from a voucher like a CNPV.

We have seen positives and risks associated with such mechanisms. We will keep our dialogue with FDA and continue to look for opportunities to accelerate anywhere we can. Right now, getting the data and moving efficiently toward an NDA is where we are focused.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Christopher W. Chen of Baird. Your line is now open.

Analyst: Hey, everyone. Thanks for taking my question and congrats on the progress. Regarding the EMERGE readout, how granular will your patient time-to-discharge data be? And if you go slightly over the eight-hour window, is it still possible to secure a label with an eight-hour treatment window?

Robert Barrow: Thanks, Chris. We are extremely detail-oriented in everything we do and aim for precise definitions of important study characteristics. We have been doing that in analyzing the end-of-session checklist and when patients can be cleared from monitoring. We will look at means, side effects, individual patient data—anything useful. It is something we are very interested in and we look forward to presenting data.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Patrick Trucchio of H.C. Wainwright & Co. Your line is now open.

Analyst: Hi. It is Arabella on for Patrick. Thank you for taking the question. Now that DEA rescheduling can be done after a successful Phase III, how much time is that realistically going to save? How are you thinking about initiating those conversations once you get the data? Also, could you comment on DT402 in ASD and what metrics or signals you are looking for to move the program forward? Thank you.

Robert Barrow: Thanks, Arabella. I believe you are referring to the executive action indicating the DEA should look at scheduling assessment after Phase III data, not after FDA approval. If implemented and DEA could as a result make a decision on scheduling at the same time as an NDA approval, that could save roughly 90 days, which is the current timeline to an interim final rule and issuance of the schedule for an approved product. We have been engaged for a while in exploring opportunities to streamline the process and enhance collaboration across federal agencies to make the timeline from FDA approval to patient access as short as possible.

With such a huge need, we should not be waiting any days we do not have to. We continue to have great dialogue with FDA, with CDER, and when able, with DEA. On DT402, I will turn it to Daniel.

Daniel Karlin: Thanks for asking about DT402. We are conducting a signal-of-efficacy study in ASD. To do that across the course of a day, we have combined a set of measures we can do repeatedly through the day—pre-dose, early in the dosing experience, late in the dosing experience, and again as the drug wears off. We constructed what might be skinnier instruments than you would ordinarily use for a regulatory approach but that include the construct components of those instruments and can be asked quickly and repeatedly.

We have patient-reported outcomes, clinician observations, caregiver observations, and digital behavioral markers (voice, facial expression, eye tracking), all rolled into a dense dosing day with as many measures as we could comfortably include for the patient experience.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Amit Daryanani of Needham & Company. Your line is now open.

Analyst: Hi, good afternoon. Thanks for taking my question. How much data do you need from Part B—where you examine how long it takes for patients to take a second, third, or fourth dose—before you submit for approval and to inform circumstances of treatment and the label? How much data do you need to have conversations with payers around coverage and pricing? Second, regarding market capacity: to achieve peak potential, how much expansion is needed in the number of clinics equipped to treat with psychedelics in the U.S., and what is the time frame or bottlenecks to see that expansion?

Robert Barrow: Thanks so much, Amit. As we approach topline data and Part A readouts, it is worth noting precedent antidepressant approvals are largely based on acute studies with post-marketing commitments for longer-term studies. We are pushing the bounds of what an acute study can do: a single dose with patients followed for 12 weeks, and in GAD a primary endpoint at 12 weeks—patients with GAD do not spontaneously have 12 weeks of significant improvement. That approach is an important component of why we are confident we will be in a great position with Part A data. Part B data will be useful to inform intervals for retreatment, retreatment patterns over time, and outcomes upon subsequent treatment.

We already have quite a bit of Part B data and will continue to aggregate across programs throughout the remainder of this year as we progress toward filing. On capacity, we think this is significantly underappreciated. Capacity that exists today is far in excess of what many models project for adoption. We do not see a capacity constraint. As we showed in New York a few weeks ago, setting up a treatment room is straightforward: have a room and someone who can be present for an extended period in a current facility. That is enough. There is not a substantial financial or logistical bottleneck—“infrastructure” is too heavy a word.

We expect capacity growth over time and will support patients and providers so they can adopt and deliver treatment if they wish. We believe there will be strong incentive and desire to adopt among treatment centers and patients.

Operator: Thank you. This concludes the question-and-answer session. I will now turn it back to CEO Robert Barrow for closing remarks.

Robert Barrow: Thank you, everyone, for joining us today. We are very excited about the quarters ahead with three pivotal readouts anticipated across the second and third quarters, and we look forward to sharing those data in due course. Thank you all.

Operator: Thank you for your participation in today’s conference. This concludes the program. You may now disconnect.