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.
RBC Capital Markets - MindMed: Rethinking brain health with psychedelic therapy https://www.youtube.com/watch?v=YTBUTnbte-8 Over the last 18 months, MindMed has undergone an extraordinary transformation. It released compelling data for its LSD-based drug MM120, followed by FDA breakthrough designation for MM120 for the treatment of GAD, and strong financial backing. CEO Rob Barrow outlines the company's ambitious goals and the path to potentially transforming mental healthcare at RBC's Global Healthcare Conference. Explore the podcast
$MNMD Psychedelic: Exclusive talk with biopharma company MindMed MNMD https://thefly.com/landingPageNews....l&utm_campaign=referral_traffic&1758208181C38 Psychedelic: Exclusive talk with biopharma company MindMedExclusive InterviewKelly Carroll - MindMed CMO talks psychedelic drug development, challenges, opportunities and more In this edition of "Psychedelic", The Fly conducted an exclusive interview with Daniel Karlin, Chief Medical Officer at Mind Medicine (MNMD), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders.
FDA’s Autism Endeavor, Pfizer’s Obesity Comeback Bid, Psychedelics Revival, ACIP Confusion, More https://www.biospace.com/drug-devel...-bid-psychedelics-revival-acip-confusion-more "Another therapeutic space primed for M&A action is psychedelics. After AbbVie bought Gilgamesh Pharmaceuticals’ lead depression asset for $1.2B last month, BioSpace spoke sought opinions from experts on who might be next to take the plunge. A few potential names included Eli Lilly, Bristol Myers Squibb and Merck."
In Waves and War - Official Trailer - Streaming on Netflix November 3rd. Psychedelic Therapy Documentary concerning veterans. Coming Soon.
MindMed (NASDAQ: MNMD) , Where it is, what matters next, and how big this could be MindMed’s thesis is simple: if you can bring a pharmaceutically optimized, well-protected form of LSD through Phase 3 in anxiety and depression, and do it within the FDA’s current playbook for psychedelics, you are no longer a “speculative psychedelics” story. You are a late-stage CNS company with first-in-class potential and real commercial line-of-sight. The clinical engine: three Phase 3 trials now running MindMed’s lead asset, MM120 ODT (an orally disintegrating tablet of lysergide d-tartrate, i.e., LSD), is in three concurrent Phase 3 studies: two in generalized anxiety disorder (GAD) and one in major depressive disorder (MDD). The company has named them for clarity, Voyage and Panorama in GAD, and Emerge in MDD. The first patient in Emerge was dosed on April 15, 2025. Emerge uses change in MADRS at Week 6 as the primary endpoint and targets ~140 U.S. participants; Voyage and Panorama are targeted at ~200 and ~250 participants respectively, with readouts guided for 2026. (Link: https://ir.mindmed.co/news-events/p...udy-of-mm120-in-major-depressive-disorder-mdd) Why confidence is (relatively) high: MM120 has FDA Breakthrough Therapy Designation in GAD, won on the back of a Phase 2b where a single 100 μg dose delivered rapid and durable reductions in anxiety versus placebo and maintained statistically significant effects through Week 12 (65% response; 48% remission). Importantly, the study intentionally avoided adjunct psychotherapy to isolate the drug effect, an approach that squares with the FDA’s guidance emphasis on clean study design. Mind Medicine (MindMed) Inc. (Link: https://ir.mindmed.co/news-events/p...udy-of-mm120-for-generalized-anxiety-disorder) The pipeline beyond MM120 remains capital-efficient: MM402 (R-MDMA) completed a Phase 1 SAD study in healthy adults; MindMed plans efficacy work in autism spectrum disorder (ASD), with the scientific angle that R-MDMA may carry less stimulant activity and abuse liability than racemic MDMA while preserving prosocial effects. This is a measured bet that keeps optionality without distracting from MM120. Mind Medicine (MindMed) Inc. (Link: https://ir.mindmed.co/news-events/p...2-2025-financial-results-and-business-updates) The formulation and IP moat: why the ODT matters Newcomers often ask: “Isn’t LSD generic?” No, MM120 ODT is a proprietary, pharmaceutically optimized form that incorporates Catalent’s Zydis® fast-dissolve technology. That matters for two reasons: (1) PK advantages (faster absorption, improved bioavailability, potentially reduced GI effects) that support dosing precision and blinding; and (2) real patents. In July 2024, the USPTO issued a patent covering the formulation, manufacturing methods, and treatment methods for MM120 ODT, extending protection to 2041. MindMed also holds exclusive rights to Zydis for lysergide across the U.S., U.K., EU, Switzerland, Israel, and Canada. That combination is the core of the moat. Mind Medicine (MindMed) Inc. (Link: https://ir.mindmed.co/news-events/p...nt-for-mm120-orally-disintegrating-tablet-odt) Share structure, cash, and runway: what our community tracks From the company’s most recent 10-Q (quarter ended June 30, 2025), common shares outstanding were ~75.8M as of quarter-end (76.1M as of July 24, 2025). The filing also details the option/RSU overhang and the legacy 2022 financing warrants that are marked to model under Level 3 fair value. On equity comp, the company adopted a 2025 Equity Incentive Plan with 4.5M new shares reserved and the ability to cover outstanding awards rolling in; total options outstanding mid-year were ~5.15M with ~1.65M vested; RSUs and PSUs are also active. This is a normal late-stage biotech cap table, just understand the potential dilution math around clinical milestones. Mind Medicine (MindMed) Inc. (Link: https://ir.mindmed.co/sec-filings/all-sec-filings/content/0000950170-25-100925/mnmd-20250630.htm) On liquidity, MindMed reported $238M in cash, cash equivalents and investments at June 30, 2025 and guided that runway into 2027, explicitly stating coverage for at least 12 months beyond the first Phase 3 GAD topline. That’s an important derisking for a company running three pivotal studies in parallel. Mind Medicine (MindMed) Inc. (Link: https://ir.mindmed.co/news-events/p...2-2025-financial-results-and-business-updates) Where the regulators’ heads are, and why MindMed’s path is different We need to be candid about the “temperature” on psychedelics. In 2024, FDA declined approval of MDMA-assisted therapy for PTSD, following a notably negative AdCom and later turbulence around trial conduct; Lykos cut staff and is regrouping for a resubmission. That cooled the near-term hype cycle and raised the bar on data integrity, blinding, and safety monitoring across the space. (Link: https://www.reuters.com/business/healthcare-pharmaceuticals/lykos-cuts-workforce-by-75-2024-08-15/) At the same time, FDA’s draft guidance on psychedelic drug trials (June 2023) already set expectations around study design, psychotherapy confounds, functional unblinding, and abuse potential. In other words, the guardrails are there, and MindMed’s clean, drug-only Phase 2b in GAD is aligned with that playbook. (Link: https://www.fda.gov/regulatory-info...-drugs-considerations-clinical-investigations) At the state level, cultural acceptance is rising but fragmented: Oregon launched the first regulated psilocybin services in 2023 (non-medical “supported adult use,” not FDA-approved therapy), and Colorado continues to build its Natural Medicine program, with facilitator licensing underway and ongoing rulemaking in 2025. This mosaic doesn’t affect MM120’s FDA path directly, but it shows a wider normalization of responsible psychedelic use, even as local bans pop up and program economics evolve. (Link: https://www.wired.com/story/oregon-psychedelics-psilocybin-rollout) The markets MindMed is chasing (TAM you can anchor to) GAD: Global GAD treatment spend is estimated at ~$2.1B in 2025, with some firms projecting high-single-digit CAGR through 2035 as awareness and treatment penetration rise. Even if you haircut third-party forecasts, the unmet need is real and long-standing (no new mechanisms in over a decade). (Link: https://www.futuremarketinsights.com/reports/generalized-anxiety-disorder-treatment-market) MDD: Global MDD drug spend is cited around $6.3B for 2025 by conservative sources (note: some methodologies exclude combos/adjacent indications, so you’ll see a wider range across vendors). The U.S. alone bears an economic burden (direct + indirect) estimated at $326B, underlining the value of fast-acting, durable treatments that could reduce total cost of care. (Link: https://www.thebusinessresearchcompany.com/report/major-depressive-disorder-global-market-report) Here’s how to think about revenue potential rather than just big TAM numbers. If MM120 wins approval in GAD first (the Breakthrough path suggests this), a single-dose, center-administered therapy with durable benefit could command procedure-like pricing, not a monthly generic SSRI price. Payer value props revolve around: (1) speed of onset, (2) durability (fewer clinic visits, reduced polypharmacy), and (3) productivity/functional outcomes. The Phase 2b signals on rapidity and 12-week durability, without adjunct therapy, are the crux of any pharmacoeconomic model. (Link: https://ir.mindmed.co/news-events/p...udy-of-mm120-for-generalized-anxiety-disorder) What we’re watching as catalysts Enrollment cadence and database locks across Voyage, Panorama, and Emerge, with company guidance pointing to first GAD topline in 1H 2026, and Panorama + Emerge in 2H 2026. Any slips or accelerations here will move the stock because the cash runway is anchored to those milestones. (Link: https://ir.mindmed.co/news-events/p...2-2025-financial-results-and-business-updates) Regulatory interactions, particularly around functional unblinding mitigation, REMS-like controls (if any), and scheduling. FDA’s stance post-MDMA will remain conservative on trial integrity and abuse potential; MindMed’s single-dose, drug-only data set is built for that conversation. (Link: https://www.fda.gov/regulatory-info...-drugs-considerations-clinical-investigations) IP prosecution and geographic coverage. The July 2024 patent and Zydis exclusivity footprint are meaningful; additional issuances or international wins would further entrench the moat. (Link: https://ir.mindmed.co/news-events/p...nt-for-mm120-orally-disintegrating-tablet-odt) MM402 pathfinding, credible ASD signal could unlock a second, differentiated value stream without heavy spend. (Link: https://ir.mindmed.co/news-events/p...2-2025-financial-results-and-business-updates) The balanced risk view, how we frame it for new money This is still drug development. The placebo problem and expectancy effects are acute in psychedelic trials; Phase 3 execution must repeat Phase 2b’s margin cleanly. Manufacturing and site operations need to be flawless; any safety outliers (hypertension spikes, psychological adverse events) will get outsize scrutiny. And on the equity side, the option/RSU overhang and legacy warrants are worth modeling into any multi-year DCF, given milestone-driven volatility. But against that, you have a fully funded pivotal program into 2027, Breakthrough in the lead indication, and an ODT IP package to 2041, a much tighter story than the sector stereotype. (Link: https://ir.mindmed.co/sec-filings/all-sec-filings/content/0000950170-25-100925/mnmd-20250630.htm) Bottom Line while waiting for next Top Line MindMed has quietly become an execution story: a Breakthrough-designated, single-dose psychedelic pharmacotherapy advancing through three pivotal studies, buttressed by defensible IP and cash to the first readout. The sector’s sentiment cooled after MDMA’s 2024 setback, but that reset actually tightens the market’s focus on clean designs and drug-only effects, exactly where MM120 has chosen to compete. If Phase 3 reproduces the Phase 2b signal in GAD and shows antidepressant benefit in MDD on the same 100 μg ODT, we’re not just looking at label wins, we’re looking at a new treatment paradigm with procedure-like pricing power and a multi-indication runway. That’s the opportunity we’re underwriting here.
