[Management View]
MindMed is advancing three pivotal phase 3 trials for MM120 ODT in generalized anxiety disorder (GAD) and major depressive disorder (MDD), with top-line results expected in 2026. The company is focused on clinical differentiation, enrollment efficiency, and commercial preparation. Cash, cash equivalents, and investments totaled $237.9 million as of Q2 2025, sufficient to fund operations into 2027.

[Outlook]
Management anticipates top-line readouts for the pivotal trials in 2026, with ongoing regulatory engagement and commercial readiness efforts. The company is preparing for MM120’s potential launch, targeting high-volume GAD clinics and conditioning the market.

[Financial Performance]
Research and development expenses increased to $29.8 million for 2025, primarily due to MM120 ODT program investment. General and administrative expenses rose to $11.1 million, driven by increased headcount for corporate growth and commercialization preparation.

[Q&A Highlights]
Question 1: Robert, there's been a lot of data that's come out by other psychedelic companies. I was just curious about your thoughts on what you've seen so far and how you think about that just relative to your programs.
Answer: It's an exciting time for the field, especially with our three pivotal readouts from GAD and MDD next year. Our phase two data showed significant and durable changes, which we hope to replicate in phase three. This magnitude and durability of impact are unique and promising.

Question 2: For the Voyager and Panorama studies, you discussed the powering assumptions and the assumed dropout rate or study discontinuation rates. Can you expand on steps you're taking to drive better retention?
Answer: The power assumptions are consistent across both studies, with 90% power to detect a five-point difference. We are optimistic about retention due to the open-label extension phase, which encourages participants to stay for the full double-blind period.

Question 3: Assuming positive Phase III data and MM120 is approved, what do you expect from real-world usage commercialization?
Answer: The extension phase allows us to observe long-term effects and real-world treatment patterns. We expect varied response patterns, with some patients needing regular redosing and others achieving sustained remission.

Question 4: Can you talk about your expectations for the durability of efficacy beyond twelve weeks and when do you expect us to see that longer-term efficacy data?
Answer: Phase two data showed no loss of separation or trend back towards baseline beyond twelve weeks. We expect similar durability in phase three and are eager to share long-term efficacy data as they become available.

Question 5: With your discussions with the FDA, can you provide any color on what may be the design of the second phase three MDD study would look like?
Answer: We haven't disclosed the design yet but are considering the inclusion of a lower dose to control for functional unblinding. We will share the rationale for our choices when the design is finalized.

Question 6: Can you give any updates with respect to the services specifically monitoring time, and time in the clinic?
Answer: We are monitoring treatment dynamics and have structured discussions with the FDA. We aim to define the timeline for individual patients and average clinic time, which we will share in the future.

Question 7: Can you comment on whether some of the sites are seeing patients screened for GAD but diagnosed with MDD rolling into the MDD trial?
Answer: Yes, we designed the studies for efficiency, allowing patients screened for GAD but diagnosed with MDD to move into the depression program, which has played out as hoped.

Question 8: Can you talk a little bit about your IP position and strategy and how important that this might be in the context of any discussions with potential partners or pharma?
Answer: We are confident in our IP strategy, filing applications on meaningful innovations. Our patents and ongoing filings position us well for discussions with potential partners.

Question 9: Is exploring opportunities for an accelerated pathway something that could make sense for MindMed?
Answer: We have breakthrough therapy designation, offering avenues for acceleration. We aim to provide robust evidence and a comprehensive program to expedite the path forward.

Question 10: How are you thinking about the appropriateness of the financial resources that are available given so many pivotal trials are running right now at MindMed?
Answer: We have built efficiencies into our phase threes and are prudent in resource allocation. Our amended debt agreement with K2 provides additional flexibility, and we are comfortable with our cash position to execute our priorities.

Question 11: How are you thinking about your MM120 in the context of the perceived fact that less time in the clinic is potentially always better when it comes to psychedelic therapeutics?
Answer: We remain confident in MM120’s activity and dynamics. The SPRAVATO model exists, and if phase two data replicate, we believe MM120 will stand out in terms of magnitude and durability of response.

[Sentiment Analysis]
Analysts and management expressed optimism and confidence in the progress of pivotal trials and the potential of MM120. The tone was positive, with a focus on strategic growth and clinical success.

[Quarterly Comparison]
| Metric | Q2 2025 | Q2 2024 | Change |
|--------|---------|---------|--------|
| R&D Expenses | $29.8M | $14.6M | +$15.2M |
| G&A Expenses | $11.1M | $9.8M | +$1.3M |
| Cash, Equivalents, Investments | $237.9M | N/A | N/A |

[Risks and Concerns]
Risks include changes in market conditions, difficulties in research and development, and regulatory approval processes. These factors could impact the company's progress and financial position.

[Final Takeaway]
MindMed is making significant progress in advancing its pivotal phase 3 trials for MM120 ODT in GAD and MDD, with top-line results expected in 2026. The company is well-positioned financially and strategically, with strong clinical site engagement and commercial readiness efforts. Management remains confident in the transformative potential of MM120 and its ability to address unmet medical needs in psychiatric disorders.