Mind Medicine (MindMed) Inc. (DFTX) Q3 FY2025 Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the MindMed Third Quarter Earnings Conference Call and webcast. [Operator Instructions] Please be advised that this conference is being recorded. I would now like to hand the conference over to our first speaker today, Gita Jain, Head of IR. Please go ahead.

Thank you, operator, and good afternoon, everyone. Thank you for joining us today for a discussion of MindMed's Third Quarter 2025 Business Highlights and Financial Results. Leading the call today will be Rob Barrow, our Chief Executive Officer. Dr. Dan Karlin, our Chief Medical Officer; and Brandi Roberts, our Chief Financial Officer, are also on the call. 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'll 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 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 the assumptions, opinions and estimates of management at the date the statements are made, including the non-occurrence of the risks and uncertainties that are described in the filings made with the SEC and applicable Canadian securities regulators or other significant events occurring outside of MindMed's normal course of business. You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, November 6, 2025. MindMed 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.

Thank you, Gita, and thank you, everyone, for joining our call today. We delivered another solid quarter, advancing our clinical programs and continuing to build one of the most robust late-stage pipelines in our field. In addition, this quarter saw the publication of our full Phase IIb clinical trial results in the Journal of the American Medical Association, highlighting the rigor and impact of the clinical results we have generated to-date. Building on this scientific momentum, we successfully completed an underwritten public offering last week, raising approximately $259 million in gross proceeds. This additional capital further strengthens our balance sheet and enables us to strategically accelerate the development of MM120 and MM402. We continue to expand and strengthen our investor base, welcoming in new high-quality health care dedicated funds and mutual funds while deepening support from our long-term shareholders. This financing underscores the strength of our science and positions us for a transformational 2026, a pivotal year ahead with 3 top line Phase III data readouts expected between our generalized anxiety disorder, or GAD, and major depressive disorder or MDD programs. Enrollment is strong and steady across our ongoing pivotal studies of MM120. We reiterate our guidance and continue to expect top line results from Voyage in the first half of 2026 and Panorama in the second half of 2026. Due to faster-than-anticipated enrollment in the past quarter, top line results from the Emerge study are now anticipated in mid-2026, an update from our prior guidance of second half of 2026. We are also excited to share further details of Ascend, our second Phase III study of MM120 in MDD, which we expect to initiate in mid-2026. We continue to deploy resources and operationalize our programs with remarkable efficiency in pursuit of approvals in both GAD and MDD, 2 of the most prevalent and burdensome psychiatric disorders. Over the course of 2025, we have continued our constructive dialogue with FDA and believe we are well positioned to deliver on an expeditious path forward in both indications. For far too long, patients struggling with anxiety and depression have been significantly underserved by current treatments. Many cycle through multiple therapies with limited success. They're looking for something different, a safe and effective new treatment option that they feel confident will deliver meaningful change, not just symptom suppression. Based on the safety, efficacy and durability we have demonstrated with MM120 ODT to date, we believe it has the potential to represent such a transformative option, addressing anxiety and depression through an efficient patient-centered delivery model. It's also important to remember that the results we have generated to date have been achieved with a single dose administered as a monotherapy without co-administered psychotherapy. We believe that MM120 ODT could integrate well into the existing health care infrastructure using well-established reimbursement codes covering evaluation, prescribing and monitoring in addition to the actual treatment itself. Our goal is to reduce administrative barriers to adoption and help ensure that providers are appropriately compensated for their time and services. With regard to our additional R&D activities, we are pleased to share an important update on our second asset in the pipeline, MM402 or the R-enantiomer of MDMA. Having already completed a single ascending dose Phase I study of MM402 in healthy adult volunteers, we plan to initiate a Phase IIa study in participants with autism spectrum disorder, or ASD, by the end of 2025. We believe ASD represents another significant opportunity with growing prevalence and substantial unmet need. As we approach the last few months of 2025, our team remains laser-focused on executing our ongoing studies and laying the groundwork for a transformational 2026 and beyond. Looking ahead, we anticipate 3 pivotal data readouts of MM120 ODT for GAD and MDD in 2026, the initiation of our second pivotal study in MDD in 2026, the advancement of MM402 in ASD into a Phase II study by the end of 2025 and further advancement of our go-to-market strategy as we prepare for the potential launch of MM120 ODT. With strong momentum across all fronts, we're working hard to bring transformative treatment options to the many patients needing new alternatives. With that, I'll turn the call over to Dan for an update on our clinical programs.

Thanks, Rob. We continue to be highly encouraged by the enrollment trends we are seeing across our pivotal Phase III studies. As Rob mentioned earlier, in GAD, we expect to report Voyage results in the first half of 2026 and Panorama results in the second half of 2026. Given the especially strong enrollment in our ongoing MDD study, Emerge, we are excited to now be in a position to report results from Emerge in mid-2026. This quarter, we also saw the publication of our full Phase IIb trial results in the Journal of the American Medical Association, or JAMA. It's a big moment, not just for us, but for the entire field of psychiatry. This study represents the most robust randomized, placebo-controlled trial of Lysergic D-tartrate or LSD in a psychiatric population using today's modern scientific standards. This trial evaluated a single treatment across 4 dose levels, 25, 50, 100 and 200 micrograms and demonstrated compelling clinical activity with a statistically significant dose response. Our optimal 100-microgram dose showed both rapid and durable effects with a statistically significant 7.7-point greater reduction in HAM-A versus placebo at week 12. Additionally, 65% of patients in the 100-microgram cohort showed clinical response and 48% achieved remission 12 weeks after the single administration of MM120. Moving to our Phase III program. Our GAD studies each have 2 parts: Part A, a 12-week randomized, double-blind, placebo-controlled assessment of MM120 ODT versus placebo; and Part B, a 40-week extension phase with open-label treatment opportunities to evaluate long-term durability and response patterns. In Voyage, we are targeting enrollment of approximately 200 participants who are being randomized 1:1 to MM120 ODT 100 micrograms or placebo, while in Panorama, we are targeting enrollment of 250 participants who are being randomized 2:1:2 to MM120 ODT 100 micrograms, 50 micrograms or placebo. These Phase III studies are modeled after our successful Phase IIb study using the Hamilton Anxiety Scale, or HAM-A, as the primary outcome measure. This was the outcome measure used for the approval of existing GAD therapies. The primary endpoint in our Phase III studies is the HAM-A change from baseline to week 12. Building on the success of our Phase IIb results, even though we observed a 7.7 point placebo-adjusted improvement in Phase IIb, we've designed our Phase III trials to have 90% power to detect a 5-point improvement over placebo. We've also designed our Phase III trials to address functional unblinding, a topic that is often raised when discussing research methods being used to investigate drugs in the broad psychedelic category. Clearly, MM120 ODT and other drugs in the category have a distinctive set of perceptual, cognitive and emotional effects at the time of administration. While the phenomenological nature of these effects is unique to the category, the vast majority of approved psychiatric drugs also have acute effects that result in participant unblinding. Even so, in order to maximize the integrity, reliability, interpretability and generalizability of our research, we have implemented a set of interventions intended to address this and other methodological considerations across our Phase IIb and Phase III programs. These include using central raters who are blinded to both treatment assignment and visit number, incorporating questionnaires to assess potential expectancy bias and unblinding, and in multiple of our studies, including additional control arms that are substantially perceivable by participants but are not of interest in assessments of clinical efficacy. Our continued interactions with FDA further support alignment with the rigor and design of our approach, reinforcing our belief that our development strategy can deliver definitive, clear and compelling evidence of the safety and efficacy of MM120 ODT in GAD and MDD. Turning to our MDD program. We are pursuing a similar approach to our GAD program, which includes 2 pivotal studies following the same 2-part design. Both of our pivotal MDD studies, Emerge and Ascend are comprised of 2 parts: Part A, a 12-week randomized, double-blind, placebo-controlled parallel group period assessing the efficacy and safety of a single dose of MM120 ODT versus placebo; and Part B, a 40-week extension period with opportunities for open-label treatment. The primary endpoint in each study is change from baseline in the Montgomery-Asberg Depression Rating Scale or MADRS, at week 6 between MM120 ODT 100 micrograms and placebo. In Emerge, we are targeting enrollment of at least 140 participants randomized 1:1 to MM120 ODT 100 micrograms or placebo. We now anticipate top line data from Emerge in mid-2026. In our second pivotal MDD study, Ascend, we are targeting enrollment of at least 175 participants randomized 2:1:2 to receive MM120, 100 micrograms, 50 micrograms or placebo. We expect to initiate Ascend in mid-2026. Moving to our next pipeline candidate. We are excited to share our plans to advance MM402, the R-enantiomer of MDMA. In preclinical studies, MM402 has shown promising prosocial effects with a potentially superior tolerability profile compared to both racemic MDMA and the S-enantiomer of MDMA. We're developing MM402 to target the core symptoms of autism spectrum disorder, specifically addressing social communication challenges. 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 MM402 in healthy adult volunteers, we plan to initiate a Phase IIa study later this year. This study will be 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 MM402 in adults with ASD across multiple functional domains. In summary, we are efficiently executing across our pipeline. Our pivotal Phase III programs for MM120 ODT in GAD and MDD remain on track for data readouts next year, and we plan to initiate Ascend, our second Phase III MDD trial in mid-2026. As we progress MM120 ODT towards commercialization, we are also excited to advance our MM402 program for ASD, furthering our mission to develop breakthrough treatments for underserved patients. With that, I'll turn the call over to Brandi to discuss our third quarter financial results. Brandi?

Thanks, Dan. Turning to our financial results for the quarter ended September 30, 2025, we ended the quarter with cash, cash equivalents and investments totaling $209.1 million. As Rob noted earlier, we successfully completed an underwritten public offering last week, raising $258.9 million in gross proceeds. After deducting underwriter commissions and expenses, net proceeds are $242.8 million. We're very pleased with the outcome of our recent financing, which puts us in an excellent position for the future. We were encouraged by the strong level of high-quality investor interest in MindMed and in our development programs, a clear reflection of the confidence the investment community has in our mission. This funding allows us to accelerate key initiatives that will set MM120 up for success, including NDA preparation, state prioritization efforts for scheduling, market research and KOL education, among others. These efforts position us well to move quickly in the years ahead, pursuing submission of an NDA for MM120 ODT as soon as possible, and if approved, executing a robust and well-prepared commercial launch. Based on the company's current operating plan and anticipated R&D milestones, the company believes that its cash, cash equivalents and investments as of September 30, 2025, along with the net proceeds from their recent offering, are sufficient to fund the company's operations into 2028. Expenses for the third quarter of 2025 were in line with our internal expectations as we continue to make significant progress with MM120 and MM402. R&D expenses were $31 million for the third quarter of 2025 compared to $17.2 million for the third quarter of 2024, an increase of $13.8 million. The overall increase was primarily due to increases of $11.7 million in MM120 program expenses, $2.5 million in internal personnel costs, reflecting expanded research and development capabilities and $200,000 in preclinical and other program expenses. These amounts were partially offset by a $600,000 reduction in MM402 program expenses. G&A expenses were $14.7 million for the third quarter of 2025 compared to $7.6 million for the third quarter of 2024, an increase of $7.1 million. The increase was primarily due to increases of $3 million in personnel-related expenses, $2 million in commercial preparedness related expenses, $1.6 million in corporate affairs expenses and $500,000 in other miscellaneous administrative expenses. Net loss for the third quarter of 2025 was $67.3 million compared to $13.7 million for the same period in 2024. Note that our net loss can be impacted dramatically by the changes in the fair value of our 2022 USD financing warrants from quarter-to-quarter as our stock price fluctuates. The change in fair value for the third quarter was $22.5 million as our stock price increased from $6.49 at June 30, 2025, to $11.79 at September 30, 2025. I'll also note that warrant exercises related to the 2022 financing have brought in approximately $2.5 million of cash this year with an additional $17.6 million of potential funding remaining prior to the warrant expirations in 2027. With that, I'll now turn it back over to Rob for closing remarks.

Thank you, Brandi. This year has been one of bold ambition and disciplined execution. We're delivering on our programs and actively shaping the future we believe is possible. Enrollment remains strong across all 3 of our ongoing pivotal trials, Voyage, Panorama and Emerge, and we are eager to continue this momentum with the initiation of our second pivotal MDD trial, Ascend in mid-2026. At the same time, we're advancing MM402 into a Phase II study, a meaningful milestone as we work to bring much needed innovation to the ASD community. 2026 is shaping up to be a defining year in our evolution, one where science, purpose and precision converge to advance the therapeutic potential of MM120 in our broader pipeline. With a strong balance sheet and a late-stage pipeline with multiple catalysts in the year ahead, we're excited to continue driving value for our shareholders and the millions of patients who deserve more than better. Of course, none of this progress will 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 the line for questions.

[Operator Instructions] And now we're going to take our first question. And it comes from the line of Gavin Clark-Gartner from Evercore.

This is Yesha on for Gavin. We just had a brief one on the blinded sample size re-estimation. Mostly wondering if this has been completed. And if so, given that the trial size expectation is still 200 patients, is it reasonable to assume that the trial is not being upsized?

Thanks so much, Yesha. Yes, we haven't disclosed anything about a public disclosure of our sample size re-estimation. And I don't know you're referring to the ability to increase the sample size to maintain 90% power in both Voyage and Panorama, our 2 GAD studies. So, we continue to be excited by enrollment and on track for a readout in that program next year but have yet to say anything publicly about those announcements.

Now we're going to our next question. And the question comes from the line of Pete Stavropoulos from Cantor Fitzgerald.