Financial Data and Key Metrics Changes - The company ended Q2 2025 with cash, cash equivalents, and investments totaling $237.9 million, which is expected to fund operations into 2027 and at least 12 months beyond the first Phase III top-line data readout for MM120 ODT and GAD [20][21] - Research and development expenses increased to $29.8 million for 2025 from $14.6 million in 2024, primarily due to the MM120 ODT program [20][21] - General and administrative expenses rose to $11.1 million for 2025 compared to $9.8 million for 2024, attributed to increased headcount [20][21] Business Line Data and Key Metrics Changes - The company is currently on track with enrollment in three pivotal Phase III trials for MM120 ODT, targeting generalized anxiety disorder (GAD) and major depressive disorder (MDD) [6][10] - The Phase III trials are designed to build on the successful Phase 2b results, with a focus on real-world implementation and efficient treatment models [7][10] Market Data and Key Metrics Changes - In the U.S., over 60 million people suffer from GAD or MDD, with more than 50% of GAD patients also experiencing MDD, indicating a significant market opportunity [6][7] - Market research indicates that 78% of interventional psychiatric providers believe psychedelic therapies will transform the treatment landscape for GAD and MDD [9] Company Strategy and Development Direction - The company aims to provide a differentiated, novel best-in-class treatment option for GAD and MDD, leveraging the unmet medical need and large commercial opportunity [6][7] - The strategic approach includes building organizational capacity and making strategic hires to support both near-term execution and long-term growth [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing pivotal trials and the potential of MM120 ODT, highlighting the FDA's breakthrough therapy designation as a significant advantage [17][22] - The company anticipates a catalyst-rich year in 2026 with top-line readouts expected from the ongoing trials [11][22] Other Important Information - The new CFO, Brandi Roberts, brings over 25 years of financial leadership experience in life sciences, which is expected to enhance the company's financial strategy during this growth phase [11][20] - The company is focused on enhancing investor communications and leading its financing strategy to ensure sufficient capital for executing priorities [20] Q&A Session Summary Question: Thoughts on data from other psychedelic companies - Management expressed excitement about the field and highlighted the significance and durability of their Phase 2 data compared to others [24][26] Question: Powering assumptions and dropout rates for studies - Management confirmed a 90% power to detect a five-point difference, with a 15% dropout rate anticipated, and emphasized the importance of open-label treatment to encourage retention [28][30][32] Question: Expectations for real-world usage and commercialization - Management discussed the design of the extension phase to observe long-term effects and establish real-world treatment patterns [33][35] Question: Enrollment trends for the VOYAGE study - Management did not provide exact enrollment numbers but confirmed that interim analysis would occur after half of the patients complete the study [39][41] Question: Durability of efficacy beyond twelve weeks - Management indicated that while formal observations beyond twelve weeks were not conducted, previous data suggested potential long-lasting effects [47][49] Question: Updates on strategic collaborations and reimbursement - Management stated that discussions with payers are ongoing, but it is premature to provide specific reimbursement details [62] Question: IP position and strategy - Management expressed confidence in their IP strategy and the protection of innovations, which is crucial for potential partnerships [80][82] Question: Financial resources for pivotal trials - Management highlighted the efficiencies built into the Phase III studies and expressed confidence in their cash position to support operations [86][88] Question: Perceived benefits of less time in the clinic for psychedelic therapeutics - Management emphasized the importance of the dynamics of MM120 and its potential to stand out in the market due to its efficacy and durability [90][92]

Financial Highlights - MindMed reported cash, cash equivalents, and investments of $237.9 million as of June 30, 2025[11], which is expected to fund operations into 2027 and at least 12 months beyond the first Phase 3 topline data readout in GAD[12, 15] - The company has a credit facility of up to $120 million, with $42 million outstanding as of June 30, 2025[63] - Operating expenses for the second quarter of 2025 totaled $40.9 million, including $29.8 million for R&D and $11.1 million for G&A[63, 66] - MindMed completed a $250 million equity investment[15, 63] Clinical Development - MM120 - The company's lead clinical program, MM120 ODT, is in three Phase 3 studies targeting Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD)[11] - Three Phase 3 topline readouts are anticipated in 2026: one in the first half for GAD (MM120-300) and two in the second half for GAD (MM120-301) and MDD (MM120-310)[14, 64] - MM120 Phase 2b trial demonstrated a 21.9-point improvement on the HAM-A at Week 12 (p=0.003) and a 48% remission rate in participants at Week 12[34] - MM120 Phase 2b also showed a 18.7-point improvement in MADRS score at Week 12, with a 6.4-point improvement over placebo (p<0.01)[38] Market Opportunity - 26 million U S adults live with GAD and 41 million U S adults live with MDD[20] - Approximately 50% of GAD patients fail first-line pharmacological treatments[20] - Approximately 2/3 of MDD patients do not achieve remission after first-line therapy, and 30% fail by 2+ lines of therapy[20] - Surveyed providers indicated that 62% of all psychiatric providers and 78% of interventional psychiatric providers believe the availability of psychedelics for GAD and MDD will change their approach to treatment[24]

Corporate Presentation May 2025 Disclaimer Cautionary Note Regarding Forward-Looking Statements This Presentation contains, and our officers and representatives may from time to time make, "forward-looking statements" within the meaning of applicable securities laws and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual res ...

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported cash, cash equivalents, and investments totaling $245.5 million, which is expected to fund operations into 2027 [19] - Research and development expenses increased to $23.4 million for the three months ended March 31, 2025, compared to $11.7 million for the same period in 2024, reflecting a significant rise due to the MM120 program [20][21] - General and administrative expenses decreased to $8.8 million for the three months ended March 31, 2025, down from $10.5 million in the same period in 2024, primarily due to lower stock-based compensation [21] Business Line Data and Key Metrics Changes - The company is actively enrolling participants in three pivotal Phase 3 trials for MM120 ODT, targeting generalized anxiety disorder (GAD) and major depressive disorder (MDD) [7][14] - The trials include Voyage and Panorama for GAD, and EMERGE for MDD, with top-line data expected in the first half of 2026 for Voyage and the second half for Panorama and EMERGE [7][15][18] Market Data and Key Metrics Changes - The company noted strong engagement from clinical sites and patients in the ongoing trials, indicating a positive market response to the MM120 program [7][14] - There is a significant unmet need for treatments addressing GAD and MDD, with over 50 million people in the U.S. alone potentially benefiting from MM120 ODT [8] Company Strategy and Development Direction - The company aims to position MM120 ODT as a best-in-class treatment for GAD and MDD, focusing on innovation and long-term value creation as it moves towards commercialization [8][22] - The recent appointment of Matt Wiley as Chief Commercial Officer is expected to enhance the company's commercial strategy during this critical growth phase [9][12] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of Mental Health Awareness Month and the company's mission to transform the treatment of brain health disorders [6] - The company remains confident in its regulatory strategy and execution across its clinical programs, with a focus on delivering meaningful value for patients and shareholders [22] Other Important Information - The company amended its loan agreement with K2 Health Ventures to provide greater financial flexibility, allowing access to up to $120 million based on milestone achievements [19] - The company is committed to ensuring participant safety in its trials, employing rigorous screening and monitoring processes to address potential suicidality risks [50] Q&A Session Summary Question: Clarification on the MDG trial and therapeutic effective dose - Management confirmed that the MDD study will not use an intermediate dose, focusing on a two-arm study with 100 micrograms versus placebo [25] Question: Insights from GAD epidemiology and treatment patterns - Management noted that there is growing awareness of GAD, which is beneficial for clinical research and potential commercialization [34] Question: Engagement with the FDA amid leadership changes - Management reported strong ongoing engagement with the FDA, with no direct impact from recent leadership changes [40] Question: Steps to limit enrolling professional patients - The company employs multiple confirmatory steps in patient selection to ensure adherence to protocol and appropriate enrollment [46] Question: Plans for interim data releases in 2025 - Management indicated that there are no plans to release unblinded data before the final readouts, focusing on executing the studies effectively [55] Question: Market dynamics and commercial planning activities - The company is confident in addressing unmet needs in GAD and MDD, with plans to refine market positioning and messaging in the second half of the year [61]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported cash, cash equivalents, and investments totaling $245.5 million, which is expected to fund operations into 2027 [20] - Research and development expenses increased to $23.4 million for Q1 2025, up from $11.7 million in Q1 2024, primarily due to costs associated with the MM120 program [21] - General and administrative expenses decreased to $8.8 million in Q1 2025 from $10.5 million in Q1 2024, attributed mainly to stock-based compensation [21] Business Line Data and Key Metrics Changes - The company is advancing its lead program MM120, targeting generalized anxiety disorder (GAD) and major depressive disorder (MDD) with three pivotal Phase 3 trials actively enrolling [6][20] - The trials, Voyage and Panorama for GAD, and EMERGE for MDD, are designed to assess the efficacy and safety of MM120 ODT [15][19] Market Data and Key Metrics Changes - The company noted a significant unmet need for treatments addressing GAD and MDD, with over 50 million people affected in the U.S. alone [7] - There is a growing awareness and recognition of anxiety disorders, which is expected to benefit clinical research and commercial opportunities for GAD treatments [37] Company Strategy and Development Direction - The company aims to position MM120 ODT as a best-in-class treatment for GAD and MDD, with a clear regulatory strategy and breakthrough therapy designation [7][22] - The new Chief Commercial Officer, Matt Wiley, is expected to lead the commercial strategy during this critical growth phase, leveraging his extensive experience in CNS and psychiatry [9][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of MM120 ODT to redefine treatment paradigms for GAD and MDD [10][22] - The company anticipates top-line data readouts from the trials in 2026, which will be crucial for future commercialization efforts [20][22] Other Important Information - The company amended its loan agreement to provide greater financial flexibility, allowing access to up to $120 million based on milestone achievements [20] - The company is committed to ensuring participant safety in clinical trials, employing rigorous screening and monitoring processes [50][51] Q&A Session Summary Question: Clarification on the MDG trial and therapeutic effective dose - Management confirmed that the MDD study will not use an intermediate dose, focusing on 100 micrograms versus placebo, and indicated that the same therapeutic dose is expected to be effective in MDD as seen in GAD [24][26] Question: Insights from GAD epidemiology and treatment patterns - Management noted that there is increasing awareness of GAD, which is beneficial for recruitment and clinical trials, and emphasized the importance of understanding treatment patterns [31][37] Question: Engagement with the FDA amid leadership changes - Management reported strong ongoing engagement with the FDA, with no direct impact from recent leadership changes [40][42] Question: Steps to limit enrolling professional patients - The company has implemented strict screening processes to ensure appropriate patient selection and adherence to trial protocols [46][48] Question: Plans for interim data releases in 2025 - Management indicated that there are no plans to release unblinded data this year, focusing instead on executing the studies and ensuring high-quality results [56][58] Question: Market dynamics and commercial planning activities - The company is confident in addressing unmet needs in GAD and MDD, with plans to refine market positioning and messaging in the second half of the year [62][65]