Corporate Presentation - September 2025 https://www.publicnow.com/view/D32F6090EDA4933F11C1AFB738B5ED9980DB1AA1
Psychedelic Medicine Is Moving from Promise to Proof: Three Things You Should Know https://www.linkedin.com/pulse/psyc...gs-ek01e/?trackingId=jsCE7423Rp2aUVRb43hltw==
'One and done' dose of LSD keeps anxiety at bay (NPR) https://www.npr.org/sections/shots-...lsd-generalized-anxiety-disorder-psychedelics
LSD-Based Med Safe, Effective for Anxiety in Phase 2B Trial (MedScape) https://www.medscape.com/viewarticl...effective-anxiety-phase-2b-trial-2025a1000nm8
Psychedelic drug popular in 1960s could ease anxiety as doctors share warnings (Fox News) https://www.foxnews.com/health/psyc...60s-could-ease-anxiety-doctors-share-warnings
H.C. Wainwright 27th Annual Global Investment Conference https://journey.ct.events/view/c1a22c93-1c8f-46ff-9ce2-c47ba55fb424
MM120 Effective as a Single Dose for Generalized Anxiety Disorder: Phase 2b Results | HCP Live Investigator Maurizio Fava, MD, chair of Mass General Brigham, discusses how MindMed’s MM120 (lysergide D-tartrate, LSD) at 100 μg signficantly reduces anxiety in adults with generalized anxiety disorder (GAD). https://www.hcplive.com/shorts/mm12...generalized-anxiety-disorder-phase-2b-results Mass General was one of the first providers in the US who offered IV ketamine for depressed people. I predict that will be one of the first adopters of this treatment as well
Here are key updated facts (mid-2025) that are relevant: Phase 3 Program for MM120 ODT MindMed is running three pivotal Phase 3 trials for MM120 ODT in generalized anxiety disorder (GAD); the Voyage and Panorama studies. A Phase 3 trial Emerge for Major Depressive Disorder (MDD) has also begun; the first patient was dosed in April 2025. The design of Emerge (MDD) includes a 12-week double-blind period (Part A) vs. placebo, and then a 40-week open-label extension. Primary endpoint in Part A is change in MADRS score at Week 6. Phase 2b Data in GAD MM120’s Phase 2b (called MMED008) showed a clear dose-response relationship, with 100 µg being identified as the optimal dose. In the 100 µg arm vs placebo: greater HAM-A reductions vs. placebo (Week 4 & sustained to Week 12: e.g., −21.3 vs −13.7 at Week 4; p < 0.0004; Cohen’s d ~0.88). Clinical response (~65%) and remission (~48%) rates at 12 weeks. Safety/tolerability were acceptable, with adverse events mostly mild/moderate, transient, and consistent with expected acute effects. Phase 2b Results were published in JAMA - https://ir.mindmed.co/news-events/p...trate-lsd-in-generalized-anxiety-disorder-gad Regulatory Progress: Breakthrough Therapy Designation (BTD) The FDA has granted Breakthrough Therapy Designation to MM120 ODT for GAD. This has been known, but posting again for new comers. Financials & Cash Runway As of June 30, 2025, MindMed had ~$237.9 million in cash, cash equivalents, and investments. Their operating expenses (especially R&D) have increased materially: R&D spend is rising sharply, driven mostly by MM120 program costs. They believe they have sufficient funds to operate into 2027, and crucially, at least 12 months beyond the first Phase 3 topline data readout in GAD. Timeline / Milestones First patient dosed in Emerge (MDD) in April 2025. Topline data from the double-blind 12-week portions of the Phase 3 GAD trials (Voyage & Panorama) & Emerge in MDD is expected in first half and second half of 2026. Other Pipelines / Programs MindMed’s other program MM402 (R(-)-MDMA) for autism spectrum disorder (ASD) has completed a Phase 1 single-ascending dose study in healthy volunteers. Further studies to assess efficacy are expected. Shares Outstanding / Capital Structure As of June 30, 2025, there were ~75.8 million common shares issued & outstanding. There are also warrants, various unvested RSUs, options, etc., which affect dilution risk. Minor all things considered. Implications for Acquisition Odds & Valuation Strategic Fit & Market Context Psychedelic / serotonergic “psychedelic-adjacent” treatments remain of strong interest, especially for mental health (GAD, MDD) given unmet need and suboptimal existing therapies (slow onset, side effects, partial responses). MindMed’s MM120 is differentiated: single-dose, rapid action, relatively clean safety signal so far. If Phase 3 data confirm these early signals, the candidate becomes highly attractive. Less in-clinic time annually compared to Spravato. See most recent company investor deck for notes on this. 8 – 32 hours for MM-120 vs 68 – 112 hours for Spravato. MM120 could have up to 56x fewer drug administration sessions and up to 14x fewer patient monitoring hours per year. Clinical Risk / Data Certainty The Phase 2b data are strong and well-powered (n ≈ 198 for GAD in Phase 2b) and provide a dose-response and signal of remission at 12 weeks. But there is still meaningful risk in translation from Phase 2 to Phase 3: replication of efficacy, safety, durability, and regulatory outcomes. For MDD, though data so far (from Phase 2b GAD) suggest antidepressant effects, it’s a leap into new indication with its own challenges. Regulatory Leverage Breakthrough Therapy Designation for GAD adds value: closer FDA interaction, potential expedited pathways, possibly more favorable labeling etc. That strengthens MindMed’s hand in either an acquisition or licensing negotiation. Financial Position & Leverage The cash runway into 2027 is relatively strong in today’s biotech climate, especially for a company with multiple late-stage trials. It gives MindMed more options: less urgent need to be acquired just to stay afloat. But burn is increasing heavily due to Phase 3 costs. MindMed will need to manage that well; any delays or added trials could pressure finances. New CFO Brandi Roberts seems to be a good fit to manage this area. Valuation Multiples & Comparable Acquisitions With Phase 3 readouts arriving in 2026, investors / acquirers will be keenly focused on those data. Before those readouts, valuation will still be somewhat speculative and heavily discounted for risk. Comparable biotech deals (especially CNS - psychedelics) have been relatively rare but instructive (except for Abbvie acquiring Gilgamesh drug candidate). The “premium” for breakthrough status, for novel mechanism, and for indication with large market (GAD, MDD) could push valuation upward if data hold up. Dilution / Capital Structure Risks Shares outstanding lower than in some earlier estimates; options, warrants, and RSUs may dilute. Any acquisition offer would have to consider these. Acquisition Likelihood & Valuations Putting it all together: Scenario Likely Valuation Range Per Share Price (~75.8 million shares) Key Drivers / Risks Conservative (trial risk, regulatory risk remains high) US$1B ‒ US$2.5B ~US$13 ‒ US$33 If Phase 3 data are weaker, safety issues, regulatory delays, or competition eats into market share. Acquisition before Phase 3 readout might come with heavy discount. Moderate (Phase 2 data holds, Phase 3 looks good, regulatory path smooth) US$3B ‒ US$5B ~US$40 ‒ US$66 Good data in GAD, decent early in MDD, no glaring safety issues, good commercial planning, increasing market appetite. Optimistic (strong Phase 3 data, regulatory fast-track, strong commercial execution) US$6B ‒ US$10B+ ~US$80 ‒ US$130+ Comparable to your earlier upper estimates; requires near best‐case outcomes: big effect sizes, high remission, rapid onset, favorable safety, payer adoption. Also likely after regulatory approval or just before commercialization.
