Same here
1 Like
Why is there no chart data or stats for MindMed?
LD-2 Disclosure Form - MindMed Lobbying on Health & Wellness issues in DC
https://lda.senate.gov/filings/public/filing/4f57d36b-4f51-4aee-9b72-f5f6e799019b/print/
Time to look back at this stock…
MindMed is targeting J&J Spravato Clinics to commercialize MM120
Here is a detailed comparison of the MindMed presentations from December 2024 and January 2025, focusing on updates and new content across various areas:
- Financial Updates
December 2024:
Reports $295.3 million in cash and cash equivalents as of September 30, 2024, with a runway expected to fund operations into 2027 based on the existing operating plan.
January 2025:
Maintains the cash runway projection but now incorporates a $250 million equity investment, emphasizing financial support for clinical trials and commercialization. It also suggests the cash runway extends 12 months beyond the first Phase 3 topline data readout for MM120.
- Pipeline and Clinical Trial Milestones
Pipeline Progress
Both Versions:
Focus on MM120 (Lysergide D-tartrate) for GAD and MDD, with MM402 (R(-)-MDMA) targeting Autism Spectrum Disorder (ASD).
January 2025:
More detailed pipeline timelines:
MM120-310 (MDD Phase 3): Initiated, with the first readout expected in 2H2025.
MM120-300 and MM120-301 (GAD Phase 3): 300 initiated in late 2024, with readouts for both planned across 2025–2026.
Clearer distinction in trial stages for MM120’s indications.
Milestones
December 2024:
Mentions initiation of MM120 Phase 3 trials for GAD and regulatory alignment with the FDA after a successful end-of-Phase 2 meeting.
January 2025:
Adds milestones such as:
Breakthrough Therapy Designation granted by the FDA for MM120.
Innovation Passport awarded by the U.K.’s MHRA for faster regulatory review.
Successful presentation of MM120 Phase 2b data at the American Psychiatric Association (APA) Annual Meeting.
- Clinical Trial Designs and Outcomes
Phase 3 Trial Designs
December 2024:
Provides general descriptions of trial phases, endpoints, and designs for GAD and MDD.
Details inclusion criteria for trials, such as HAM-A ≥20 for GAD and MADRS ≥26 for MDD.
January 2025:
Expands on trial design with updates:
GAD Phase 3 (MM120-300 & MM120-301):
Increased participant count: MM120-301 now 250 participants (2:1:2 randomization) vs. earlier 200 participants.
Adaptive design clarified for re-estimation of sample size based on interim results.
MDD Phase 3 (MM120-310):
Maintains 140 participants but emphasizes biweekly assessments and follow-ups for sustained efficacy monitoring.
Phase 2b Results
Both Versions:
Highlight statistically significant results for MM120 in GAD:
HAM-A reduction: -21.9 points vs. placebo (p=0.003).
48% remission rate and effect size d=0.81, over double the standard of care.
January 2025:
Provides deeper data visualization for:
Remission and response rates (e.g., 65% response rate vs. 31% for placebo at 100 µg dose).
HAM-A severity progression from baseline through Week 12, showing most participants achieving remission.
- Regulatory and Strategic Developments
Regulatory Updates
December 2024:
Mentions general alignment with FDA guidance and adherence to 2023 Draft Guidance for Psychedelic Drug Trials.
January 2025:
Elaborates on regulatory achievements:
Breakthrough Therapy Designation for MM120 in GAD.
Patents granted for MM120 covering formulation, manufacturing, and treatment methods, with protection through 2041.
Strategic Focus
January 2025:
Emphasizes a pre-launch strategy for MM120, aiming to streamline commercialization through:
Partnerships with interventional psychiatry clinics.
Targeted stakeholder education on the unmet needs in GAD and MDD.
Alignment with existing reimbursement frameworks.
- Commercialization Framework
January 2025:
Introduces a bold strategy for integrating MM120 into clinical practice, leveraging:
The Spravato (esketamine) delivery infrastructure with over 4,500 certified centers.
Proven reimbursement pathways for medical and pharmacy benefits.
Highlights the quadruple aim:
-
Better patient outcomes.
-
Improved clinician satisfaction.
-
Enhanced patient experiences (e.g., reduced clinical burden).
-
Lower healthcare costs due to early intervention.
-
Messaging and Presentation Enhancements
December 2024:
Focused primarily on clinical and operational updates.
Limited emphasis on commercial value and stakeholder engagement.
January 2025:
Refined messaging to highlight MM120’s value proposition:
Describes MM120 as a transformational innovation for brain health, shifting treatment paradigms from chronic symptom suppression to rapid and durable improvement.
Enhanced graphics and layout for better communication of key clinical outcomes and strategic milestones.
Summary of Key Additions in January 2025
New financial backing ($250M equity investment).
Enhanced regulatory and patent achievements.
More detailed trial designs and updates to participant frameworks.
Comprehensive commercialization strategy tied to existing infrastructure.
Stronger messaging on MM120’s transformative potential and alignment with evolving psychiatric treatment trends.
Link to January 2025 Presentation - https://d1io3yog0oux5.cloudfront.net/_f4300da83811ab83bafcbd424342228f/mindmed/db/2265/21500/pdf/MindMed+January+2025+Corporate+Presentation.pdf
Links to December 2025 Presentation - https://docs.publicnow.com/viewDoc?filename=133467%5CEXT%5C26C6B9D0565C6A323CB4372ED6B4AAB83F1A96DF_51CCCCDA60B64C1065AEB09DA309238E1625DA7D.PDF
Reminder the presentations on MindMed will be replaced and old version links will not work when they have updated to a new one.