Definium (DFTX) Q4 2025 Earnings Call Transcript

Motley Fool Transcribing, The Motley FoolFri, February 27, 2026 at 5:09 PM UTC

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Thursday, Feb. 26, 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

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TAKEAWAYS -

Pipeline Milestone -- EMERGE, the first pivotal Phase III study in major depressive disorder (MDD), is fully enrolled, with top-line data expected in late Q2.

VOYAGE Enrollment -- Enrollment is approximately 80% complete in the VOYAGE Phase III study for generalized anxiety disorder (GAD), with completion expected in the coming weeks and top-line data targeted for early Q3.

Sample Size Reestimation -- The preplanned blinded sample size reestimation for VOYAGE is complete, requiring no increase in sample size, suggesting statistical power may exceed 99% if interim nuisance parameters persist.

ASCEND Launch -- ASCEND, the second pivotal Phase III study in MDD, has activated its first sites, with initial dosing anticipated by early Q2.

PANORAMA Progress -- Enrollment in PANORAMA, the second GAD Phase III study incorporating European sites, is described as rapidly progressing, with further updates planned for April.

Phase IIb Results -- The preceding Phase IIb study for DT120 showed a placebo-adjusted improvement of 7.7 points on the Hamilton Anxiety Scale (HAMA) and 6.4 points on the Montgomery-Asberg Depression Rating Scale (MADRS) at week 12.

Absolute Response Metrics -- DT120 achieved a 21.9-point reduction in HAMA and 18.7-point reduction in MADRS at week twelve in Phase IIb, with a 48% clinical remission rate in GAD and a 65% response rate.

Study Power and Design -- Phase III MDD studies are powered at 80% to detect a five-point MADRS improvement over placebo at week six; GAD studies are powered at 90% for a five-point HAMA improvement at week twelve.

Research & Development Spend -- Full year 2025 research and development expenses reached $117.7 million, an increase of $52.4 million primarily due to DT120 advancement, expanded personnel, and offset by a $2 million reduction in DT402 spending.

General & Administrative Spend -- General and administrative expenses totaled $486 million, a $10 million increase primarily due to professional services, pre-commercialization, and personnel-related costs, partially offset by legal-related reductions.

Net Loss -- Net loss for 2025 was $183.8 million, up from $108.7 million the prior year, with a $22.8 million change in fair value of USD financing warrants attributed to the stock price rising from $6.96 to $13.39.

Cash Position -- Cash, cash equivalents, and investments at year-end 2025 totaled $411.6 million, compared to $273.7 million at year-end 2024, which management states is sufficient to fund operations into 2028.

Commercial Readiness -- The commercial team is fully assembled, with key hires in marketing, market access, and operations, and infrastructure is being built to address REMS, regulatory, operational, and reimbursement pathways for prospective launches.

DT402 Development -- Phase IIa trial of DT402 (R-enantiomer of MDMA) for autism spectrum disorder has dosed its first participant and is designed as an open-label single-dose study with initial data expected later in 2026.

Definium Therapeutics (NASDAQ:DFTX) expects three pivotal Phase III readouts for DT120 in anxiety and depression during 2026, with the first (EMERGE in MDD) reporting in late Q2. Management reported that top-line VOYAGE GAD data will follow in early Q3, with both enrollment efficiency and blinded interim analysis indicating statistical power above initial assumptions. The company ended 2025 with $411.6 million in liquidity, affirming operational funding into 2028 and ongoing investment in commercial infrastructure for potential launches.

Barrow described regulatory alignment with the FDA under Breakthrough Therapy designation as positioning the company for a rapid New Drug Application (NDA) submission if data are positive.

Karlin said, “Among the first 100 participants who completed week twelve, we saw a model-based standard deviation of 6.7 points on the HAMA and a nonevaluable rate of 10%.”

The PANORAMA study’s blinded interim analysis and enrollment status are scheduled to be disclosed at the April Analyst Day.

DT120 dosing regimen and monitoring requirements are under high-granularity assessment, with detailed patient discharge timing to be reported when sufficient data aggregations are available.

The commercial launch model emphasizes a “high-touch, white-glove experience,” including a hub-service support model designed to address provider operational complexity and reimbursement clarity.

Pricing strategy for DT120 was not specified, with management citing continued market research and payer interaction, and emphasizing patient access removal of friction points.

INDUSTRY GLOSSARY -

DT120 ODT: Orally disintegrating tablet formulation of lysergic tartrate, Definium’s lead late-stage psychedelic drug candidate for GAD and MDD.

DT402: R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA) being developed for autism spectrum disorder core symptoms.

HAMA: Hamilton Anxiety Scale, a clinician-administered rating scale used to assess anxiety severity.

MADRS: Montgomery-Asberg Depression Rating Scale, a ten-item diagnostic questionnaire used to measure the severity of depressive episodes.

REMS: Risk Evaluation and Mitigation Strategy, a required safety program by the FDA for certain drugs.

Nonevaluable rate: The proportion of trial participants lacking endpoint data at measurement due to attrition or protocol deviations.

Full Conference Call Transcript

Rob Barrow, our Chief Executive Officer, who is joined by Dr. Dan Karlin, our Chief Medical Officer, Brandi Roberts, our Chief Financial Officer, and Matt Wiley, our Chief Commercial Officer. An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call. During today's call, we will be making certain forward-looking statements, including, without limitation, statements about the potential safety, efficacy, 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 applicable Canadian securities regulators, including our Annual Report on Form 10-K filed today. Forward-looking statements are based on the 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, 02/26/2026.

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 Rob.

Robert Barrow: Thank you, Gita, and thank you, everyone, for joining our call today. We are incredibly excited to share today's updates as we rapidly approach our anticipated pivotal readouts for lysergic tartrate, or DT120 ODT, in generalized anxiety disorder and major depressive disorder in the months ahead. The momentum is palpable, both across our development programs and in the world of psychiatry as we prepare for the adoption of psychedelics as potentially transformative new treatment options. We continue to believe in the potential of DT120 ODT as a best-in-class product candidate, and over the past year, our team has yet again set the standards for scientific rigor, efficiency, and thoughtfulness in execution.

As I reflect on 2025, I could not be prouder of our team and the progress we have made. Over the course of the last year, we rapidly progressed our late-stage pipeline, significantly strengthened our balance sheet, and continued to expand our world-class leadership team and Board of Directors to drive our next phase of growth. Through ongoing engagement with the FDA under the Breakthrough Therapy designation program, we reached alignment on many key aspects of our development and submission strategy, positioning us to maximize the speed and efficiency of our NDA submission for DT120 ODT, subject to positive trial readouts later this year.

Our commercial strategy and organizational readiness have mirrored these R&D successes, with the addition of key commercial leadership led by Matt Wiley, who joined as our Chief Commercial Officer in March 2025. We have seen strong engagement across the spectrum, positioning us to deliver on our aim to yet again define the standard of excellence in the adoption of psychedelics. We began 2026 with the launch of Mind Medicine (MindMed) Inc., a refreshed brand that reflects the evolution of our company and our leadership in psychiatry. Our differentiated strategy, grounded in disciplined execution, scientific rigor, and an ambitious view of the impact we can drive, positions us to develop scalable, accessible treatments and drive long-term value for our shareholders.

With three Phase III readouts expected in 2026, the first of which is just months away, we expect the year ahead to be a pivotal one, both for Mind Medicine (MindMed) Inc. and psychiatry at large. Our goal is clear: to address the urgent need for a new class of drugs that can offer meaningful relief to the millions of people who are living with GAD and MDD, disorders that have long been underserved by treatments with high burden, moderate efficacy, and often poor tolerability.

Building on our strong dose-optimization Phase 2b study, which was published in JAMA last September, our clinical program for DT120 ODT consists of four pivotal Phase III studies: two in GAD, the VOYAGE and PANORAMA studies, and two in MDD, the EMERGE and ASCEND studies. I am pleased to share today that EMERGE, our first pivotal study in MDD, is fully enrolled, and we anticipate delivering top-line data in late Q2. And while EMERGE is the last of our three ongoing pivotal studies to be initiated, we could not be more excited to share this readout first across our phase three programs.

This sequencing both provides the opportunity to establish evidence in a second major market indication and enables us to engage with FDA with ample time to explore potential opportunities for accelerating our regulatory submission strategy for the MDD and GAD indications. We have also made significant progress in launching ASCEND, our second pivotal study in MDD. Our first sites in ASCEND have been activated, and we anticipate first participant dosing by early Q2. Onto our GAD program, we continue to see strong enrollment across VOYAGE and PANORAMA.

Enrollment in VOYAGE is approximately 80% complete, and based on the enrollment rate and current queue of patients, we expect to conclude enrollment in the coming weeks, with top-line data expected in early Q3. I am also happy to share that the preplanned blinded sample size reestimation is complete, with no required increase in sample size. Dan will be sharing further details on the sample size reestimation in a few moments. Enrollment in PANORAMA, our second Phase III study in GAD, is rapidly progressing, and we remain on track to deliver top-line data in 2026.

We plan to provide a further enrollment update and to disclose the outcome of the PANORAMA blinded sample size reestimation at our Investor and Analyst Day in April. Our team remains focused on delivering high-quality data across our Phase III studies, targeting two of the largest and most impactful indications in psychiatry. We continue to believe in the best-in-class potential of DT120 ODT and are dedicated to the scientific rigor and disciplined execution that has defined our organization and successes to date. With that, I will turn the call over to Dan to share additional details on our clinical programs.

Daniel Karlin: Thanks, Rob. We remain highly encouraged by the enrollment trends we are seeing across our Phase III GAD and MDD studies. We have been spending a lot of time with our sites and investigators, and there is a high degree of excitement and engagement as we get closer to delivering top-line data. As Rob mentioned, we are especially excited to deliver EMERGE as our first pivotal readout in late Q2.

While our Phase II Montgomery-Asberg Depression Rating Scale, or MADRS, results in GAD have given us great clinical confidence, through the design and execution of EMERGE we have not previously had the opportunity to establish the efficacy of DT120 in a dedicated MDD population with patients in a major depressive episode. While GAD and MDD are substantially overlapping disorders, MDD is defined as an episodic illness with periods of normal mood interrupted by major depressive episodes, which are characterized by dysthymia or depressed mood that must persist for at least two weeks and may last many months. GAD is described as a more continuous state of heightened anxiety.

In our GAD program, starting with Phase 2b, we demonstrated DT120’s remarkable ability to improve this continuous background condition, while our MDD program is intended to demonstrate the same effect on the course of major depressive episodes. Taken together, these data suggest that if approved, DT120 may represent a data-driven, evidence-based clinical choice for providers and patients with the potential to improve patient outcomes, whether the patient is currently in a major depressive episode or not.

Each of our four pivotal studies across GAD and MDD is comprised of two parts: Part A, a 12-week randomized, double-blind, placebo-controlled, parallel-group period assessing the safety and efficacy of a single dose of DT120 ODT versus placebo; and Part B, a 40-week extension period with opportunities for open-label treatment. The primary endpoint in our MDD studies is the change from baseline in MADRS score at week six between DT120 ODT 100 micrograms and placebo. The MDD trials were designed with 80% power to detect a five-point improvement over placebo on this endpoint.

The primary endpoint in our GAD studies is the change from baseline in the Hamilton Anxiety Scale, or HAMA, at week twelve between DT120 ODT 100 micrograms and placebo. The GAD trials were designed to have 90% power to detect a five-point improvement over placebo on this endpoint. Our Phase III studies are modeled after our successful Phase 2b study, in which we observed placebo-adjusted improvement of 7.7 points on the HAMA and 6.4 points on the MADRS at week 12.

In the context of other approved pharmacotherapies, which have typically shown a placebo-adjusted effect of less than four points on these endpoints, we believe DT120 has the potential to be not only a best-in-class product among psychedelics, but among anxiolytics and antidepressants broadly. And while placebo-adjusted changes are critically important for establishing efficacy, the absolute magnitude of improvement may be a more representative measure of the real-world patient experience. This is where DT120 even further stood out, having demonstrated a 21.9-point reduction in HAMA scores at week twelve, corresponding with a 48% clinical remission rate and a 65% response rate. In addressing comorbid depressive symptoms, we saw an 18.7-point absolute reduction in MADRS scores at week twelve.

I will now recap progress with our MDD studies. Enrollment is complete, and we expect to deliver top-line data from EMERGE in late Q2. Based on the progress in EMERGE, we are moving forward with the execution of our second pivotal MDD study, ASCEND. In ASCEND, we are targeting enrollment of approximately 175 participants randomized two-to-one-to-two to receive DT120 ODT 100 micrograms, 50 micrograms, or placebo. Our first sites in ASCEND have been activated, and we expect to begin dosing by early Q2.

We expect ASCEND to continue to benefit from operational efficiencies that enabled the rapid enrollment of EMERGE, including the ability to fast-track select sites that participated in EMERGE and those that are actively enrolling in our GAD program. Regarding our GAD program, we are in the final stages of enrollment in VOYAGE, with completion anticipated in the coming weeks. In VOYAGE, we are targeting enrollment of approximately 200 participants randomized one-to-one to DT120 ODT 100 micrograms or placebo, while in PANORAMA, we are targeting enrollment of 250 participants randomized two-to-one-to-two to DT120 ODT 100 micrograms, 50 micrograms, or placebo.

Each GAD study includes a sample size reestimation that allows for adjustment of the target enrollment based on a blinded evaluation of nuisance parameters. As Rob mentioned previously, we completed the sample size reestimation for VOYAGE and determined that no increase in the trial sample size is required. In the initial study power calculation, we assumed a standard deviation of 10 points and a nonevaluable rate of 15% at week twelve. Among the first 100 participants who completed week twelve, we saw a model-based standard deviation of 6.7 points on the HAMA and a nonevaluable rate of 10%. These observations suggest that the study's ability to detect a statistically significant drug effect substantially exceeds the planned power.

In fact, if these nuisance parameters were to remain unchanged in the final analysis, this would imply that the study has over 99% power to detect a five-point difference on the HAMA, and that the minimum difference required to achieve statistical significance would be less than two points. Beyond DT120, we are excited to have initiated our Phase II study of DT402 in autism spectrum disorder, or ASD, in late 2025. 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 symptoms of ASD, specifically addressing social communication that is central to the experience of the disorder.

We believe this program represents another significant treatment opportunity given the high unmet need, the increasing prevalence of ASD, and no FDA-approved therapies that specifically address these core symptoms. Having completed a Phase I single-ascending-dose study that characterized the tolerability, pharmacokinetics, and pharmacodynamics of DT402 in healthy adult volunteers, we dosed the first participant in our Phase IIa study, and initial data is expected later this year. This study is a single-dose, open-label design assessing early signals of efficacy in up to 20 adult participants with ASD. The objectives and endpoints of the study are designed to characterize the pharmacodynamics and clinical effects of DT402 across multiple functional domains.

Across our late-stage pipeline, we are making strong progress and rapidly approaching multiple pivotal readouts for our DT120 ODT program. We believe the remarkable profile of DT120 has the potential to be best in class among GAD and MDD pharmacotherapies, and we are confident in our strategy and execution to drive the broadest possible impact for the millions of patients in need. Now I will turn it over to Matt for commercial comments on DT120.

Matthew Wiley: Thanks, Dan. As an organization, we are deeply committed to and focused on impeccable commercial readiness for the potential launches in GAD and MDD. Over the past year, we have comprehensively mapped the provider landscape nationwide, and in close collaboration with our cross-functional internal teams, prioritized key states for launch. If approved, we are fully positioned to execute rapidly and with precision. Our vision for Mind Medicine (MindMed) Inc. commercialization is to deliver a genuinely high-touch, white-glove experience for our providers, one that extends the collaborative, partnership-oriented approach that has distinguished us throughout our clinical development and with our trial sites.

This philosophy has been a key differentiator for us, and we intend to make it a foundational element of our commercial model. We fully appreciate that providers will have multifaceted needs beyond just product information. They will seek clear guidance on REMS certification, regulatory requirements, operational integration, and reimbursement pathways. Accordingly, we are building the robust infrastructure and cross-functional teams required to address these elements seamlessly and support providers from day one. To strengthen our launch capabilities, we have assembled an exceptional commercial leadership team over the past year in marketing, market access, and operations. This leadership team comes with deep experience in navigating complex launches, including experience with REMS and scheduled drugs.

Their proven track record gives us tremendous confidence as we prepare for launch. We look forward to sharing more detail on our commercialization strategy at our upcoming Analyst Day on April 22. But stepping back, our message is simple: we are preparing to introduce something meaningfully different. Historically, when new classes of medicines have been introduced in psychiatry, they have generated significant value and delivered multibillion-dollar opportunities. We believe DT120 has the potential not only to participate in that kind of opportunity but to improve on what has come before, most importantly for patients who urgently need more than better. With that, I will turn our call over to Brandi to discuss our full year 2025 results. Brandi?

Brandi L. Roberts: Thanks, Matt. Research and development expenses were $117,700,000 for the year ended 12/31/2025, compared to $65,300,000 for the year ended 12/31/2024, representing an increase of $52,400,000. This increase was primarily driven by $44,700,000 in higher DT120 program expenses, $9,300,000 in internal personnel costs reflecting expanded research and development capabilities, and $400,000 in preclinical and other program expenses, partially offset by a $2,000,000 reduction in DT402 program expenses. General and administrative expenses were $486,000,000 for the year ended 12/31/2025, compared to $38,600,000 for the year ended 12/31/2024, an increase of $10,000,000.

The increase was primarily attributable to $6,000,000 in professional services and pre-commercialization activities, $3,600,000 in personnel-related expenses to support expanded operational activities, $700,000 in director’s deferred share unit expense driven by our year-over-year stock price appreciation, and $500,000 in other administrative expenses, partially offset by a $800,000 reduction in legal and patent-related expenses. Overall, our R&D and G&A expenses for 2025 were in line with our internal expectations as we continue to make significant progress across the DT120 and DT402 programs. Net loss for the year ended 12/31/2025 was $183,800,000 compared to $108,700,000 for the year ended 12/31/2024. As a reminder, our net loss can be significantly impacted by changes in the fair value of our 2022 USD financing warrants.

During 2025, the change in fair value was $22,800,000, reflecting an increase in our stock price from $6.96 at 12/31/2024 to $13.39 at 12/31/2025. We ended 2025 with cash, cash equivalents, and investments of $411,600,000 compared to $273,700,000 at year-end 2024. Based on our current operating plan and anticipated milestones, we believe our cash, cash equivalents, and investments as of 12/31/2025 will be sufficient to fund operations into 2028. We are pleased to enter 2026 with the financial flexibility to accelerate several key initiatives, including NDA preparation, market access priority activities, market research, and KOL education. These investments are intended to support our path to market and, if DT120 ODT is approved, enable a well-prepared and robust commercial launch.

We are also encouraged by the continued evolution of our investor base, with strong engagement from existing shareholders and growing interest from new investors as we progress through 2025. As we look ahead to a very important year in 2026, our focus remains on disciplined execution, thoughtful capital allocation, and advancing our programs in a way that supports long-term value creation. I will now turn the call back to Rob for our closing remarks.

Robert Barrow: Thank you, Brandi. 2025 was a year of bold ambition and disciplined execution. In 2026, Mind Medicine (MindMed) Inc. is set to deliver some of psychiatry's most important data, highlighting our progress and ambition to bring novel, scalable therapies to patients underserved by today's standard of care. With a strong balance sheet and a late-stage pipeline with multiple catalysts in the months ahead, we are excited to continue driving value for our shareholders and the millions of patients who deserve more than better. Of course, none of this progress would be possible without our exceptional team, whose passion, commitment, and unmatched execution continue to set the standard for our field. Thank you again for joining our call today.

We will now open for questions.

Operator: Thank you. Ladies and gentlemen, to ask a question, please press 11. To withdraw your question, simply press 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Andrew Tsai with Jefferies. Your line is now open.

Andrew Tsai: Hey. Good afternoon. Thanks for the updates. Thanks for taking my question. For this interim that you did, it is very interesting for VOYAGE. I am curious, in the hypothetical scenario where the DMC asked or recommended you to upsize the trial, what would have been effectively the placebo-adjusted delta for that to happen, give or take? And just to confirm, there were no other scenarios with this interim such as stopping for futility or even stopping for success? Thanks.

Robert Barrow: Yeah. Thanks so much for the question, Andrew. So this is a blinded sample size reestimation, and an important feature of that analysis is that we do not ever unblind the study, we do not do any inferential testing, and as a result, we do not actually learn anything about the performance of the two groups independently or in relation to one another. Effectively, you can think of it as looking at the right side of the plus-or-minus on the 95% confidence interval to assess the standard error and ensure that the assumptions we made at the beginning of the study are reflected, or we do not lose power because we made wrong assumptions.

And so there was no implication, there is no learning or inference that can be derived either from this analysis or from any other outcome of the analysis. But we are certainly excited to see that we are good with assumptions we made and, if anything, as Dan mentioned during the call, have certainly adequate power at 99% or greater if the current variables hold, nuisance parameters hold. And we are eager to get the study results and ultimately do that inferential test and look at the performance of 120 versus placebo.

Andrew Tsai: Wow. Okay. Thanks. And then really quickly, by the time you topline the VOYAGE data now in early Q3, would you consider piecemealing some of the Part B open-label extension data just to further showcase how durable a single dose of 120 could be? Otherwise, when would you share the open-label portion? Thanks.

Robert Barrow: Yeah. Absolutely. One of the things we have been really focused on is, of course, the durability and the response patterns over the course of an entire year. And, of course, all of the studies have been running for quite a while now. And so as we continue to accrue patients who have gone through certain milestones and either events of retreatment or have made it through a fixed interval of time, we will have, of course, increasing data and increasing confidence in those data to be able to share some insights. So we have not firmed up a commitment as to exactly when we would present Part B data.

We certainly do not want to get ahead of ourselves and present data that we do not feel are representative or that we are not confident in at any time. So we will certainly be taking a look at that, and as we accrue those data, be it at any of the readouts from the ongoing studies or another time, we will have an opportunity to share as much insight as we possibly can about performance in Part A and Part B.

Andrew Tsai: Right. Makes sense. Again.

Operator: Thank you. Our next question comes from the line of Mark Goodman with Leerink. Your line is now open.

Basma Radwan Ibrahim: Good afternoon. This is Basma on for Mark. Thank you for taking our question. Our first question is on the interim look. Again, have you conducted the interim look for PANORAMA as well, or not yet? And are you planning to do it once you hit 80% enrollment, similar to VOYAGE? And also, regarding the MDD, when are you going to plan to do the interim look exactly for the EMERGE trial? Our second question is for the GAD readout. What are your expectations regarding the remission rate? What would you consider as a good and differentiated rate versus the standard of care? Thank you. That is it for us.

Robert Barrow: Yes. Thanks so much, Basma. So in terms of the interim analysis for VOYAGE, we, of course, announced that today. For PANORAMA, our second pivotal study in GAD, we will be sharing additional details and enrollment updates at our Analyst Day in April. For the two MDD studies, of course, EMERGE is now fully enrolled, and the top-line data that we would be sharing would be the completed final top-line analysis from that study. So we are not conducting an interim look on either of the MDD studies currently.

In terms of GAD and the remission rate, I will turn it over to Dan to comment about our thinking around response patterns and ultimately what drives patient experience and value in these populations.

Daniel Karlin: Yeah. It is a great question about the remission rate because we have obviously talked about that from our Phase 2b outcomes. I think it is important to note that mostly what we know about pharmacotherapy-induced remission rate comes from MDD studies, and in MDD, what you see with an SSRI, the first-line treatment that is most commonly used, is an attributable remission rate in the real world of something in the 10% to 30% range. But, of course, it is difficult to necessarily interpret those data because MDD is necessarily a cyclical illness, and when a major depressive episode is resolved, whether with meds or without, then that is a period of remission from the symptoms.

We made some design choices in Phase III for both GAD and MDD, which was to target open-label treatments, so the Part B treatments, to the threshold between mild and moderate illness on the HAMA and the MADRS. So in this case, what we are really looking at is, given the availability of open-label treatment in the Part Bs, are we able to treat people down into that mild or better range reliably with the redosing.

So while we are not a priori specifying what we would hope for from an absolute remission rate, what we are intending here to do is to get people out of moderate or worse illness and see how well we can keep them in mild or better.

Operator: Thank you. Our next question comes from the line of Evercore ISI. Your line is now open.

Evie (Evercore ISI): Hi. You have Evie on for Gavin. Congratulations on all the progress made this year. It is great to see that the SSRE is now complete. Any color you could provide on enrollment and how it is trending for the second GAD and MDD trials, seeing as VOYAGE data is now expected by early Q3? And our second question is, in addition to the SSRE and variability, can you speak to anything else giving you incremental confidence? Could be something like baseline characteristics, OLE rollover retention, screen failures, or anything like that. Thank you.

Robert Barrow: Yes. Thanks so much for the question. So, in terms of enrollment updates, of course, with EMERGE, our first MDD study now fully enrolled and data expected in late Q2, we have just been overwhelmed by how fast we were able to enroll that study and how excited we think that represents the field and the researchers who are working on this study have been and are about the potential here. We certainly are, and our team has done an incredible job at executing on these studies.

In terms of VOYAGE, we shared that we are approximately 80% enrolled, and we continue to see incredibly strong enrollment with our best months yet, and so we absolutely are seeing the continued growth and acceleration in enrollment across the program. For our second study, PANORAMA, again, we will be sharing further updates at our Analyst Day in April, but we have been encouraged across the board and really happy with where we are in enrollment in that study. ASCEND will also, of course, be starting in the coming weeks.

We are really excited to get studies activated, faster than even we anticipated, and the ability to get studies DEA activated and DEA approvals in place in a matter of just a few weeks has allowed us to really accelerate the start of that second study in MDD. So, really across the board, we have been very encouraged by the enrollment trends and where that positions us for three pivotal readouts over the course of this year. In terms of incremental confidence, we will not be commenting on specific variables or what we are seeing in those variables.

We are extraordinarily confident in the profile of 120, and as Dan mentioned during his prepared remarks, with the observed parameters that we saw in the interim analysis for VOYAGE, that would imply a quite high, over 99% power to detect a five-point difference and less than two points required in terms of the separation between the groups in order to achieve a statistically positive result if those variables are the same at the end of the study as they were at the interim analysis. So it gives you quite a bit of confidence if the study only has to show a couple of points’ difference to get a statistically positive outcome.

Of course, we would hope to see better than that. We think that a four-point difference between the arms is something we would really like to see that would really stand out as the best results we have seen in GAD to date. And so we are certainly excited to deliver those data, but all that we are seeing across all of the studies gives us continued confidence in the program and positions us really well for these readouts later in the year.

Evie (Evercore ISI): Thank you.

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

Brian Abrahams: Hey. Good afternoon, guys. Thanks for taking my questions. Congrats on all the progress and looking forward to a very exciting, data-rich year. Two for me. I guess first, you have had some slight changes in the enrollment timelines versus prior expectations in both directions, and I am curious the impact that has on your views of the addressable populations of patients with these respective conditions who may be interested in a psychedelic. And then just with the interim passing and, obviously, the low variability and dropouts, it sounds like a very narrow delta could still be statistically significant in VOYAGE.

So can you maybe elaborate a little bit more on your latest views on clinically meaningful delta, and really how would hitting stat sig with a smaller delta potentially impact your plans in PANORAMA as well as how you would see the drug positioned commercially? Thanks.

Robert Barrow: Yeah. Thanks so much, Brian, and both are great questions. I will turn it over to Dan to talk about the first one. And, Dan, maybe you can reflect on how we think about these populations and also how these patients, of course, show up in trials and show up for clinical attention.

Daniel Karlin: Yeah. It is an excellent question and a good observation, and while the timeline changes do not necessarily change how we think about the patient population, certainly what we know is that in the current environment in psychiatry and with the drugs that are currently available, MDD has been a target of both drug development and clinical focus for really the last thirty years or so and left GAD a bit behind, with no new drugs approved in GAD since 2007.

The reality is that this is a massively overlapping patient population, and while GAD is a more continuous background condition that people live with day by day, in many cases for much of their life, that both makes people not necessarily seek care—they are used to being the way they are, even if it is quite disruptive to their lives—but it is not an acute change that people notice in their lives as they do when they enter a major depressive episode, which often drives people to seek care.

So we are really excited about the opportunity to potentially provide a drug here that, regardless of what induces someone to go seek care—whether it is this ongoing state of anxiety or newly developed anxiety or entering a major depressive episode, which represents a real state change for them—the way we think about this is that regardless of the driver of the presentation, we intend to provide a body of evidence that demonstrates that DT120 would be a good choice for the patient. So that gives us some temporal flexibility for people in the course of their lives and in the course of their illness.

Robert Barrow: Yeah. Thanks, Dan. Brian, in terms of your second question about clinical meaningfulness, it also is a great one. You know, I think it is really important contextually, both in terms of that difference and in terms of the overall magnitude of change. I think there are certainly a lot of different approaches out there to these concepts. In our minds—Dan mentioned this a little bit in the prepared remarks—but in the real world, patients, of course, do not get placebo.

So while we definitely want to demonstrate as large a placebo-adjusted response as we can, observing an absolute magnitude of change that stands out relative to the other options that are available—there are always limitations comparing across studies and such—but we think that is an important variable to focus on as well. When it comes down to that placebo-adjusted change, again, when we are talking about drugs that we believe have the potential to be transformative, we think that should also be reflected in terms of the consistency with which patients are seeing the benefit and the magnitude of benefit over placebo.

And so while, yes, we are very encouraged when we have a low clinical bar relative to where we started and where we powered the study, we absolutely would like to see a change that stands out and continues to stand out as we saw in Phase II. And in GAD, when we look at the landscape of currently approved therapies, not one of them consistently delivers at or above a four-point delta over placebo in those studies. And so if we are seeing a magnitude of change that is as large or larger than those, and the placebo-adjusted change that is larger than four points, it is hard not to get incredibly excited about that in our mind.

So while we do not set a bright line on any of these kinds of concepts, we very much are looking for data that impress and data that get us, and we think payers and providers and everyone, excited about the potential because we certainly believe it is there and hope the data stand up to support that.

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Brian Abrahams: Thank you.

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

François Brisebois: Hi. Thanks for taking the questions. A lot of interesting questions, a lot of interesting answers too. I was just wondering, you touched on the four-point kind of bar that is not a hard bar or anything, but it is something that you have been mentioning on the GAD side.

Can you just remind us, now that MDD will be first, can you do the same exercise in terms of what you would like to see and compare it to what has been seen for MDD, and maybe also remind everyone what you had seen previously on the MADRS side in the prior trial and maybe caveats around what you had seen because the trial was not necessarily for that originally.

Robert Barrow: Yes. Hey. Thanks so much for the question, Brian. I mean, when we look at the landscape of approved products and products that are in development, we continue to be encouraged qualitatively in the research we have done to date. Dan mentioned that what we saw is in the GAD population with milder illness. I think we really focus a lot on the severity of both MDD and GAD because those severities are representative of impact on patients and drive a lot of the burden and the value.

And so as we think about the response, we think about severity and that overall magnitude of change, and that is, again, where we saw really impressive results on both symptom sets—on anxiety symptoms and depression symptoms. So we saw a 6.4-point difference between 120 and placebo in MADRS scores, and basically that was starting from a lower point than what we would expect in a dedicated MDD population, patients in a major depressive episode.

We will certainly be completing that picture, I think, more comprehensively as we get to the Analyst Day in April, and as we get closer and closer to the readouts, we want to set full context for those expectations and for the realities of that landscape. But when we look at that today, again, seeing a placebo-adjusted effect that is greater than four points seems quite important, and seeing a double-digit absolute magnitude of change also seems quite important in our minds. And that is true especially in the MDD population where taking patients from severe depression symptoms to high moderate, or low severe, would not represent a major change in our minds.

And so as we think about this readout, we again want to see a large absolute magnitude of change and as large of a placebo-adjusted change as the drug can deliver.

François Brisebois: Okay. Maybe if I could just get the last one there. In terms of when you do some work on it, you hear a lot of comments around, from going from Phase II to Phase III, it is totally normal to get a smaller delta with placebo. Is that something that makes sense to people? Is there a reason behind that, or is that just kind of protecting yourself a little bit?

Robert Barrow: Yeah. No. I think the reality is that we have certainly, in historical studies in psychiatry, there are studies at times where that happens. I think where we see—and we have seen this in schizophrenia, we have seen this in a number of other indications as well—where some of the best performing drugs continue to not see that sort of compression as they progress in development. So the design changes, operational changes, those sorts of things have an impact, and that is why we have been so encouraged with our approach in Phase III.

We designed our Phase II program to be exactly executed and designed like a Phase III study, although we thought it critically important to establish a dose response and select the appropriate dose to take into the pivotal studies, which is why we did the Phase II the way we did. That also means we made minuscule operational changes between the Phase II and Phase III studies—we are virtually doing the same thing over again, just with two or three arms instead of five arms as in Phase II. So that, again, gives us a lot of confidence.

And then there are a number of dynamics in the study design that we think will drive better patient retention through the primary outcome of these studies. Dan mentioned that the nonevaluable rate that we saw in the interim analysis in VOYAGE was 10%. You compare that to over 25% in our Phase II data, which we think is largely driven by the fact that we are seeing with Part B, the nine-month extension period, patients have an ability to access open-label 120 if they complete the full twelve-week blinded control period. And so all of those dynamics give us a lot of confidence about operationalization of these studies and give us a lot of confidence as we approach data.

François Brisebois: Thank you. That is it for me.

Operator: Thank you. Our next question comes from the line of Cantor Fitzgerald. Your line is now open.

Unknown Analyst: Hi. Good afternoon. Nice to see the progress, and thank you for taking our questions. First one, just curious to hear how you are thinking about a potential filing strategy. If the two GAD Phase IIIs are positive, and if the first Phase III MDD study EMERGE is positive, will you complete two MDD studies before filing an sNDA? Or is there a reason to wait for the second study?

Robert Barrow: Yeah. Thanks so much for the question. It would be premature to comment specifically on filing strategy given that we do not have data in hand. But certainly, we think that the stronger the data, the more compelling an argument a sponsor can make, and that is true across the board. And so we will be looking very closely at the data, and if we are seeing an impressive result, both placebo-adjusted and absolute magnitude of change—something that gets us quite excited—we will very much be engaging in those conversations to explore the most efficient pathway forward for both indications.

Unknown Analyst: And then just to touch on your earlier-stage asset, now 402, if you can give us a little bit of color in terms of assessing clinical effect, which scales are key for you? And in your deck and in the press release, it mentions functional biomarkers. Can you just elaborate on that?

Robert Barrow: Yeah. I will turn that one over to Dan to comment on.

Daniel Karlin: Yeah. Happy to comment on that, and thanks for asking about 402. Obviously, with all the excitement around 120, sometimes we do not get a chance to comment on this as much as we would like to because we are really excited about the program. We have gotten through a single-ascending-dose safety study, which gives us good data for dosing in a single-dose paradigm, which is exactly what we said we have done, which is to bring the drug forward in a single-dose, open-label paradigm. And the question of measurement in ASD is always an interesting one.

You are asking after the scales, and the other scales that have been used in attempts at approval before—of course, with no approved drugs for the core symptoms of the disorder—the right measure at the right time remains a pretty open conversation, both in the field with experts who treat folks with ASD and with regulators who are eager to be able to approve drugs for this condition that really does not have treatments that target its core symptoms. What we are looking at in the current early signal of efficacy study are measures that have high granularity.

So we want high-sensitivity and high-granularity measures so that we are able to repeatedly measure over the course of a dosing day to look at change that is consistent with the expected PK and PD of the drug. We have not talked about exactly what measures we are using, but we are using components of established measures along with some novel ways of looking at social interaction, social communication, and the other domains where we think that the drug will be effective.

So we are considering measurement from the outset and very much thinking about measurement techniques that can track along with the drug through its phases of development and ultimately through to regulatory submission, if and when we get there, and potentially the measures that could travel with the drug out into the world if it is approved.

Unknown Analyst: Right. Thank you, and congrats once again.

Operator: Thank you. Our next question comes from the line of Baird. Your line is now open.

Christopher W. Chen: Good afternoon. Thanks for taking my question, and congrats on the progress. I had a question regarding MDD. One of the things we hear about SPRAVATO is that it is good at alleviating symptoms of TRD, but not so good at increasing overall productivity of daily life—like productivity at work, for example. I know you are measuring a number of quality-of-life metrics in EMERGE, but I am particularly interested in the WPAI. So if you do not mind expanding on your expectations there, and can you provide any high-level color on what you are hearing about how these patients are doing beyond just MDD symptom alleviation? And then I have one more after that.

Robert Barrow: Yeah. Thanks, Chris. I will turn it over to Dan to talk about WPAI. I would first say that with the dosing regimen that is required to go into a clinic for multiple hours, at least one time a week for a long time, being at work is certainly going to be a thing that drives productivity. So a treatment where you have to come in infrequently, which is able to establish the same kind of durability as we have seen in trials so far, is certainly something that we think would differentiate 120 from anything that is out there in the world today. That would be a pretty important impact.

It is going to the doctor's office once or twice a week that is quite a burden, and so even beyond the actual measurable productivity, the presence at work and being able to do that is going to be an important driver, and it is really something that also shows up in patient satisfaction and overall utilization of the drug, we would think. But I will turn it to Dan to elaborate on the WPAI.

Daniel Karlin: Yeah. You know, the domains that the WPAI looks at—absenteeism, not being able to make it to work; presenteeism, being impaired while at work—and it tries to assess an overall percentage of impairment while at work. Of course, this is not a primary outcome, and we are not looking to try to demonstrate efficacy overall based on a scale like this. But I think, as you observe, this is really important, right? Just having lower reported symptoms or suppressed symptoms does not necessarily mean that someone is back and able to do the things that they need to do and want to do in their lives.

We very much are oriented toward the idea that, just as we saw in Phase II, the experience of participants after treatment—because, of course, unlike SPRAVATO, where the treatment is a continuous, intermittent course—we anticipate having long periods of time between treatment, if such retreatment is even always necessary. The way that folks described their experience post-treatment in Phase II was less about, as you are pointing out, symptom suppression and more about having an outlook that was changed. As it relates to the future in GAD and, obviously, as we hope to see in MDD, as it relates to the anhedonia, or inability to take pleasure in activities that would generally give the person pleasure.

So we are measuring whether 120 represents a more whole-person change toward a state of what could be called recovery.

Christopher W. Chen: Great. That is very helpful. And then, just a quick one. Are you collecting patient time-to-discharge data in these trials? And if so, are you seeing anything that may suggest any shifts from that six- to eight-hour monitoring period?

Robert Barrow: Yeah. It is a great question, and we are absolutely collecting high-granularity data. We think it is critically important to have data-driven arguments and a data-driven understanding of what is happening on a dosing day, and to ultimately characterize that to inform regulatory discussions. We start assessing—we have a structured set of assessments that we measure on an hourly basis starting at hour five—and we, of course, observe all patients regardless of the dose or whether they receive placebo through hour eight in the study.

At the end of the day, we expect to have, again, a high-granularity assessment of the different domains and ultimately the time at which patients are able to be discharged safely, we think, from a treatment session. Given that we have a number of open-label treatment sessions, we have some insights there which we cannot share quite yet in great detail. We want to aggregate enough data to feel confident in sharing that before we do so.

But certainly, as we progress and as we get to a top-line readout, we think it is really important, given the nature of these drugs, to start characterizing that—something we have been doing with a really thoughtful approach beginning with our Phase II study and certainly being refined and giving us increasing confidence as we have gotten through the conduct of a Phase III program. Thank you.

Operator: Thank you. Our next question comes from the line of Eight Capital. Your line is now open.

Arabella Ng: Hi. This is Arabella on for Patrick. Thank you so much for taking the question, and congrats on all the progress. We are looking forward to the upcoming readout. Since PANORAMA also includes your European sites, are there any meaningful differences in diagnostic, placebo behavior, or standard of care that could introduce additional variability?

Robert Barrow: Yeah. I will send that one over to Dan.

Daniel Karlin: It is an excellent question and a good observation. The PANORAMA study does include European sites, and while there are, as you note, in the practice of psychiatry, regional variations—even within the United States different areas of the country have different practice patterns—and the diagnostic criteria remain the same, the way they are applied can be different from place to place. We work our way through that by being very highly specified in our protocols, so diagnostic criteria that we use are standard from one country to the next and one site to the next, of course, and the way they are applied is standardized, and that standardization is supervised and monitored from beyond the site level.

All of our participants have really a three-part confirmatory set of assessments, only one of which is based on the site assessment. We have central diagnostic confirmation and central severity confirmation so that it takes that kind of site variability out. Another advantage in this patient population is because we take both—in the case of GAD, which is where the European sites are—and MDD, because we are not dedicating enrollment in our studies on some set of past treatments or having been failed by some set of past treatments, local treatment pattern variation is not going to have an impact on who we bring into the trial.

So we are incredibly confident that across sites here in the States and sites in Europe that we are getting the participants who we intended to get into the study. And because we are testing as a monotherapy, of course we are getting participants independent of what might be local patterns for the treatment of these disorders.

Operator: Great. Thank you so much. And then really quickly, I know we already touched on it, but specifically for GAD, I know it is still early: if both VOYAGE and PANORAMA are positive, would that allow you to file, or is there any additional long-term data or anything else that might gate submitting an NDA?

Robert Barrow: Of course, it is premature to talk finally about filing strategy and filing dynamics until we have had a final discussion with FDA in a pre-NDA meeting. But based on a really positive dialogue we have had with FDA throughout our pivotal programs, we feel highly encouraged that delivering Part A data, durability data out to twelve weeks, is what we need for filing. And so as we get to top-line data from these studies, we are already doing a ton of work to get ourselves ready to be in a position to file as quickly as possible, and again, try to set that standard for how efficient and how quickly we can race across the finish line.

Operator: Perfect. Thank you so much. Our next question comes from the line of Ami Fadia with Needham and Company. Your line is now open.

Ami Fadia: Hi, good afternoon. Thanks for taking my question and congrats on all the progress. My question was on—firstly, just on the MDD program. You indicated that the study is 80% powered to show a five-point change, and in your GAD study on MADRS, you have seen a 6.4 change. What I want to understand is from a commercial perspective, in order to be able to tap into a meaningful portion of the MDD market—not just, you know, the patients that are treatment resistant—what type of a profile would you like to see?

And then secondly, as you think about the regulatory landscape and how that is changing and the recent FDA stance on wanting to move towards a one-trial requirement, do you think you still need two studies in each of the two indications, or would there be opportunity to explore fewer studies should maybe the studies this year turn out to be positive? Thank you.

Robert Barrow: Yeah. Thanks very much, Ami. I will take them in reverse order and ask Matt to comment on your first question. In terms of regulatory stance, the statutory requirements for drug approvals have been in place for quite a while. We are incredibly encouraged to see some of the dialogue around efficient pathways and regulatory understanding and flexibility, although we are going to continue to hold ourselves to the highest standards of rigor. That all said, these are highly overlapping indications, and we are seeing, of course, and measuring symptoms of anxiety and symptoms of depression across all four of the studies.

And so aggregating a large body of evidence—if we are seeing consistent results across multiple studies, across multiple domains, a high degree of both standalone and placebo-adjusted change—the better the data are, the stronger the arguments are going to be, whether it is one, two, or more studies for any program. And so we will certainly take all of that into consideration and, depending on the strength and magnitude of responses that we are seeing across these studies, be in a position to chart a regulatory path forward there. To the first point, again, I think it is a little bit premature to talk overly precisely about segmentation or about exactly where this would land in the commercial setting.

I will turn it over to Matt to comment on how we think about that and the expectations and hopes for both commercial adoption and reimbursement and such.

Matthew Wiley: Yeah. Thanks, Rob, and thanks for the question. As it pertains to the patient profile in MDD, first of all, we take a step back and look at both these indications. These are highly prevalent indications. There are over 50 million patients in the United States for both indications, and there is still very significant unmet need. As we conduct market research with HCPs, we see that the unmet need is greater than 70% across both indications. So even with the care that they have access to today, there is still something left significantly lacking in the treatment paradigm.

We know that payers do manage drugs, and branded drugs that enter the market typically have a step or two, and so we believe that can narrow the overall addressable market slightly. But there are, for both GAD and MDD, a significant number of patients that are going to benefit, if approved, from DT120.

Operator: Alright. I appreciate the response. Thank you. Our next question comes from the line of Sumant Kulkarni with Canaccord. Your line is now open.

Sumant Satchidanand Kulkarni: Good afternoon. Thanks for taking our questions as we eagerly await all the data you expect to announce this year. I have two questions, one on product development and the other on the commercial side. First, conceptually, we think investors are perhaps somewhat unfairly holding psychedelic therapeutics to a higher bar on point separations on scales in clinical trials, but our view for some time now has been that where the bar really should be different versus standard of care is on durability of effect. Is that a fair real-world characterization from your perspective?

And I am asking that because I think I heard an explicit callout for durability in your earlier answer on clinical relevance of a stat-sig score on HAMA or—and perhaps even more so—on MADRS.

Robert Barrow: Yeah. No. Thanks so much for the questions. When we think about durability, there are both the practical limitations of how long out in time you can look at single-dose durability in a placebo-controlled manner. There are certainly insights that we can gain beyond that in our conduct of the studies—we will be looking at the response patterns and the ultimate duration to events beyond just a twelve-week period.

But when we look at the landscape, twelve weeks is the outer bound of what most studies—particularly drugs that do not require a long time; for instance, SSRIs can take many weeks to show any sort of activity—and so, of course, sponsors who dose studies would wait well beyond that to try to drive that separation. But when we think about durability, and our dialogue with regulators to date, an ability to show durability at twelve weeks past a single intervention is really at or close to the highest bar one could set for a drug.

And so part of the decision-making and the design of the Phase III program was to have our primary endpoint be at that time, which would be showing, if successful in these studies, really the longest durability of response that we could hope to be established within a parallel-group phase of the study. And that stands out among all of the chronic candidates that we are seeing in late-stage development, certainly in our field. So we absolutely agree that durability is important, and that durability well beyond a few weeks after a single treatment or, you know, the last treatment or dose is really meaningful and why we have designed our studies the way we have.

Sumant Satchidanand Kulkarni: Got it. Yeah. That is really why I was asking, because you have shown really good durability so far. And on the commercial side, Matt, you mentioned a “high-touch, white-glove” experience. What are your latest thoughts on pricing in MDD and GAD, at least relative to SPRAVATO for TRD, if that is still a good benchmark? And what fraction of that high-touch, white-glove experience can be paid for by insurers?

Robert Barrow: Yeah. I will just say briefly, we are not throwing that—when we think about pricing, it is certainly premature to talk specifically about pricing. But when we think about the dynamics, we continue to believe and build conviction in our beliefs that the failure of currently available therapies to address a patient’s depression or anything else is not a good proxy to define a population, and that what we see also in a lot of our HEOR work is that severity is a huge driver of disease burden—it should not be surprising.

The fact that drugs that do not work particularly well in a population have not worked in the population does not mean that those who were underserved by those therapies are worse off necessarily. And so while we understand the dynamics of likely not being a first-line therapy for everyone, we do think that those distinctions are somewhat artificial. As a result, we both can look at subpopulations in our studies but would not shy away from things like SPRAVATO as a comparator, given the artificiality of that distinction. I will turn it over to Matt to comment further on that.

Matthew Wiley: Yeah. So, Sumant, as we think about the high-touch or white-glove type of orientation we have for this launch, it is really to remove any friction that a patient or provider could experience. That will involve a hub service model, being really clear on the reimbursement pathway, how to bill and code, etc., ensuring that the patient out-of-pocket is not an obstacle—basically removing any of the obstacles to get to therapy as quickly as possible.

That is our ambition; that is what we are building toward, whether it is through field team and high-touch field team exposure to either HCPs or otherwise, in market access, and ensuring that we have a seamless hub model that really helps coordinate all of the different touchpoints to ensure that the patient experience is positive.

Operator: Thank you. And that is all the time we have for our question and answer session. I will now turn the call back over to Mr. Rob Barrow for any closing remarks.

Robert Barrow: I just thank everyone again for joining us on the call today. We are incredibly excited to come to our top-line readout for EMERGE first in the months ahead, and with three pivotal readouts across the course of the year, we think this is really a defining year for us and are incredibly excited to get to those data readouts. Thank you again for joining us today, and I hope you will join us at our upcoming events in April and thereafter.

Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.

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